Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-29 @ 9:32 PM
Study NCT ID:
NCT01802151
Status:
COMPLETED
Last Update Posted:
2015-12-17
First Post:
2013-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Bacillus Subtilis R0179 in Healthy Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wdahl@ufl.edu', 'phone': '352-392-1991', 'title': 'Dr. Wendy Dahl', 'phoneExt': '224', 'organization': 'Department of Food Science and Human Nutrition, University of Florida'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Data monitoring adverse events was collected over the study period.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.\n\nPlacebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'B. Subtilis R0179 (0.1 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.', 'otherNumAtRisk': 21, 'otherNumAffected': 1, 'seriousNumAtRisk': 21, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'B. Subtilis R0179 (1 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'B. Subtilis R0179 (10 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.', 'otherNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrheal Symptoms', 'notes': 'One participant in the 0.1 billion CFU treatment group experienced diarrheal symptoms and completed the study, this event did not occur in any other participants and did not persist.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Itchiness and Redness Symptoms', 'notes': 'A participant in the 10 billion CFU treatment group experienced itchiness/redness symptoms that were sporadic and persisted for several days. The participant voluntarily withdrew from the study, these symptoms did not occur in any other participants.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hypotension', 'notes': 'One participant reported a serious adverse event of hospitalization with an admitting diagnosis of hypotension, but did not discontinue probiotic consumption and completed the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.\n\nPlacebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.'}, {'id': 'OG001', 'title': 'B. Subtilis R0179 (0.1 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}, {'id': 'OG002', 'title': 'B. Subtilis R0179 (1 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}, {'id': 'OG003', 'title': 'B. Subtilis R0179 (10 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}], 'classes': [{'title': 'Daily Questionnaire (GI Distress) Week 1', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '0.1', 'groupId': 'OG003'}]}]}, {'title': 'Daily Questionnaire (GI Distress) Week 2', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '0.1', 'groupId': 'OG003'}]}]}, {'title': 'Daily Questionnaire (GI Distress) Week 3', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '0.6', 'spread': '0.1', 'groupId': 'OG003'}]}]}, {'title': 'Daily Questionnaire (GI Distress) Week 4', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.01', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '0.1', 'groupId': 'OG003'}]}]}, {'title': 'Daily Questionnaire (GI Distress) Week 5', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '0.1', 'groupId': 'OG003'}]}]}, {'title': 'Daily Questionnaire (GI Distress) Week 6', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '0.4', 'spread': '0.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed all study requirements were included in the baseline analysis population.'}, {'type': 'SECONDARY', 'title': 'Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.\n\nPlacebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.'}, {'id': 'OG001', 'title': 'B. Subtilis R0179 (0.1 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}, {'id': 'OG002', 'title': 'B. Subtilis R0179 (1 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}, {'id': 'OG003', 'title': 'B. Subtilis R0179 (10 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}], 'classes': [{'title': 'GI Viability of Bacillus Spores Week 1', 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '1.2', 'spread': '0.2', 'groupId': 'OG003'}]}]}, {'title': 'GI Viability of Bacillus Spores Week 5', 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '5.6', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '6.4', 'spread': '0.1', 'groupId': 'OG003'}]}]}, {'title': 'GI Viability of Bacillus Spores Week 6', 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '2.1', 'spread': '0.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Viability of B. subtilis R0179, recovered from stool samples, was assessed using one way ANOVA followed subsequently by Tukey-Kramer HSD when significance was reached (p\\<0.05). Data was normalized when appropriate. Data analyzed was log (CFU/g).', 'unitOfMeasure': 'log CFU/g', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed all study requirements were included in the baseline analysis population.'}, {'type': 'PRIMARY', 'title': 'Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.\n\nPlacebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.'}, {'id': 'OG001', 'title': 'B. Subtilis R0179 (0.1 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}, {'id': 'OG002', 'title': 'B. Subtilis R0179 (1 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}, {'id': 'OG003', 'title': 'B. Subtilis R0179 (10 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}], 'classes': [{'title': 'Daily Questionnaire (Cephalic) Week 1', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.04', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG003'}]}]}, {'title': 'Daily Questionnaire (Cephalic) Week 2', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.04', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG003'}]}]}, {'title': 'Daily Questionnaire (Cephalic) Week 3', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.04', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '0.1', 'groupId': 'OG003'}]}]}, {'title': 'Daily Questionnaire (Cephalic) Week 4', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.03', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '0.1', 'groupId': 'OG003'}]}]}, {'title': 'Daily Questionnaire (Cephalic) Week 5', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG003'}]}]}, {'title': 'Daily Questionnaire (Cephalic) Week 6', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed all study requirements were included in the baseline analysis population.'}, {'type': 'PRIMARY', 'title': 'Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.\n\nPlacebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.'}, {'id': 'OG001', 'title': 'B. Subtilis R0179 (0.1 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}, {'id': 'OG002', 'title': 'B. Subtilis R0179 (1 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}, {'id': 'OG003', 'title': 'B. Subtilis R0179 (10 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}], 'classes': [{'title': 'Daily Questionnaire (Epidermal) Week 1', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.01', 'groupId': 'OG002'}, {'value': '0.03', 'spread': '0.01', 'groupId': 'OG003'}]}]}, {'title': 'Daily Questionnaire (Epidermal) Week 2', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.01', 'groupId': 'OG001'}, {'value': '0.04', 'spread': '0.02', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.02', 'groupId': 'OG003'}]}]}, {'title': 'Daily Questionnaire (Epidermal) Week 3', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.04', 'groupId': 'OG002'}, {'value': '0.05', 'spread': '0.03', 'groupId': 'OG003'}]}]}, {'title': 'Daily Questionnaire (Epidermal) Week 4', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.01', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.02', 'groupId': 'OG003'}]}]}, {'title': 'Daily Questionnaire (Epidermal) Week 5', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.01', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.02', 'groupId': 'OG002'}, {'value': '0.02', 'spread': '0.02', 'groupId': 'OG003'}]}]}, {'title': 'Daily Questionnaire (Epidermal) Week 6', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.02', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.01', 'groupId': 'OG002'}, {'value': '0.02', 'spread': '0.02', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed all study requirements were included in the baseline analysis population.'}, {'type': 'PRIMARY', 'title': 'Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.\n\nPlacebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.'}, {'id': 'OG001', 'title': 'B. Subtilis R0179 (0.1 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}, {'id': 'OG002', 'title': 'B. Subtilis R0179 (1 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}, {'id': 'OG003', 'title': 'B. Subtilis R0179 (10 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}], 'classes': [{'title': 'Daily Questionnaire (ENT) Week 1', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.04', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '0.04', 'groupId': 'OG003'}]}]}, {'title': 'Daily Questionnaire (ENT) Week 2', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.03', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '0.04', 'groupId': 'OG003'}]}]}, {'title': 'Daily Questionnaire (ENT) Week 3', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG003'}]}]}, {'title': 'Daily Questionnaire (ENT) Week 4', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG003'}]}]}, {'title': 'Daily Questionnaire (ENT) Week 5', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG003'}]}]}, {'title': 'Daily Questionnaire (ENT) Week 6', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '0.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed all study requirements were included in the baseline analysis population.'}, {'type': 'PRIMARY', 'title': 'Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.\n\nPlacebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.'}, {'id': 'OG001', 'title': 'B. Subtilis R0179 (0.1 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}, {'id': 'OG002', 'title': 'B. Subtilis R0179 (1 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}, {'id': 'OG003', 'title': 'B. Subtilis R0179 (10 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. 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Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed all study requirements were included in the baseline analysis population.'}, {'type': 'PRIMARY', 'title': 'Evaluation of the Effect of B. 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Subtilis R0179 (1 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}, {'id': 'OG003', 'title': 'B. Subtilis R0179 (10 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}], 'classes': [{'title': 'Daily Questionnaire (Bowel Mov.) Week 1', 'categories': [{'measurements': [{'value': '1.55', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '1.5', 'spread': '0.1', 'groupId': 'OG003'}]}]}, {'title': 'Daily Questionnaire (Bowel Mov.) Weeks 2-5', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '1.5', 'spread': '0.1', 'groupId': 'OG003'}]}]}, {'title': 'Daily Questionnaire (Bowel Mov.) Week 6', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '0.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Daily scores from weeks 2 - 5 were then averaged to arrive at a single value. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed all study requirements were included in the baseline analysis population.'}, {'type': 'PRIMARY', 'title': 'Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.\n\nPlacebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.'}, {'id': 'OG001', 'title': 'B. Subtilis R0179 (0.1 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}, {'id': 'OG002', 'title': 'B. Subtilis R0179 (1 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}, {'id': 'OG003', 'title': 'B. Subtilis R0179 (10 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}], 'classes': [{'title': 'Daily Questionnaire (Hours of Sleep) Week 1', 'categories': [{'measurements': [{'value': '6.8', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '7.1', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '6.6', 'spread': '0.2', 'groupId': 'OG003'}]}]}, {'title': 'Daily Questionnaire (Hours of Sleep) Week 2', 'categories': [{'measurements': [{'value': '6.7', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '7.1', 'spread': '0.2', 'groupId': 'OG002'}, {'value': '6.9', 'spread': '0.2', 'groupId': 'OG003'}]}]}, {'title': 'Daily Questionnaire (Hours of Sleep) Week 3', 'categories': [{'measurements': [{'value': '6.5', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '7.1', 'spread': '0.2', 'groupId': 'OG002'}, {'value': '6.7', 'spread': '0.2', 'groupId': 'OG003'}]}]}, {'title': 'Daily Questionnaire (Hours of Sleep) Week 4', 'categories': [{'measurements': [{'value': '6.6', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '7.3', 'spread': '0.2', 'groupId': 'OG002'}, {'value': '6.8', 'spread': '0.2', 'groupId': 'OG003'}]}]}, {'title': 'Daily Questionnaire (Hours of Sleep) Week 5', 'categories': [{'measurements': [{'value': '6.8', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '6.9', 'spread': '0.2', 'groupId': 'OG002'}, {'value': '6.9', 'spread': '0.2', 'groupId': 'OG003'}]}]}, {'title': 'Daily Questionnaire (Hours of Sleep) Week 6', 'categories': [{'measurements': [{'value': '6.8', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '7.1', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '6.7', 'spread': '0.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Participants recorded the number of hours they slept on the daily questionnaire.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed all study requirements were included in the baseline analysis population.'}, {'type': 'PRIMARY', 'title': 'Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.\n\nPlacebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.'}, {'id': 'OG001', 'title': 'B. Subtilis R0179 (0.1 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}, {'id': 'OG002', 'title': 'B. Subtilis R0179 (1 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}, {'id': 'OG003', 'title': 'B. Subtilis R0179 (10 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}], 'classes': [{'title': 'GSRS (Abdominal Pain) Week 1', 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '1.5', 'spread': '0.2', 'groupId': 'OG003'}]}]}, {'title': 'GSRS (Abdominal Pain) Week 5', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '0.1', 'groupId': 'OG003'}]}]}, {'title': 'GSRS (Abdominal Pain) Week 6', 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '1.3', 'spread': '0.1', 'groupId': 'OG003'}]}]}, {'title': 'GSRS (Reflux) Week 1', 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '1.1', 'spread': '0.1', 'groupId': 'OG003'}]}]}, {'title': 'GSRS (Reflux) Week 5', 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '1.2', 'spread': '0.1', 'groupId': 'OG003'}]}]}, {'title': 'GSRS (Reflux) Week 6', 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '1.2', 'spread': '0.1', 'groupId': 'OG003'}]}]}, {'title': 'GSRS (Indigestion) Week 1', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '0.01', 'groupId': 'OG002'}, {'value': '1.7', 'spread': '0.1', 'groupId': 'OG003'}]}]}, {'title': 'GSRS (Indigestion) Week 5', 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '0.1', 'groupId': 'OG003'}]}]}, {'title': 'GSRS (Indigestion) Week 6', 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '1.7', 'spread': '0.1', 'groupId': 'OG003'}]}]}, {'title': 'GSRS (Constipation) Week 1', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '1.4', 'spread': '0.1', 'groupId': 'OG003'}]}]}, {'title': 'GSRS (Constipation) Week 5', 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '0.2', 'groupId': 'OG002'}, {'value': '1.8', 'spread': '0.2', 'groupId': 'OG003'}]}]}, {'title': 'GSRS (Constipation) Week 6', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '0.2', 'groupId': 'OG002'}, {'value': '1.7', 'spread': '0.2', 'groupId': 'OG003'}]}]}, {'title': 'GSRS (Diarrhea) Week 1', 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '0.2', 'groupId': 'OG002'}, {'value': '1.4', 'spread': '0.1', 'groupId': 'OG003'}]}]}, {'title': 'GSRS (Diarrhea) Week 5', 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '0.2', 'groupId': 'OG002'}, {'value': '1.5', 'spread': '0.1', 'groupId': 'OG003'}]}]}, {'title': 'GSRS (Diarrhea) Week 6', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '0.2', 'groupId': 'OG002'}, {'value': '1.3', 'spread': '0.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1, 5, and 6', 'description': 'Gastrointestinal Symptom Questionaires (GSRS) was administered during weeks 1, 5, and 6 of the study to evaluate gastrointestinal symptoms. The scale ranges from 1 (no discomfort at all) to 7 (very severe discomfort).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed all study requirements were included in the baseline analysis population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.\n\nPlacebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.'}, {'id': 'FG001', 'title': 'B. Subtilis R0179 (0.1 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}, {'id': 'FG002', 'title': 'B. Subtilis R0179 (1 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}, {'id': 'FG003', 'title': 'B. Subtilis R0179 (10 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': "Participants were enrolled and randomized in five waves. The final wave's data collection ended 9/20", 'groupId': 'FG000', 'numSubjects': '20'}, {'comment': "Participants were enrolled and randomized in five waves. The final wave's data collection ended 9/20", 'groupId': 'FG001', 'numSubjects': '21'}, {'comment': "Participants were enrolled and randomized in five waves. The final wave's data collection ended 9/20", 'groupId': 'FG002', 'numSubjects': '20'}, {'comment': "Participants were enrolled and randomized in five waves. The final wave's data collection ended 9/20", 'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Healthy adults were recruited by flyers and word of mouth on the University of Florida campus. Rolling recruitment (7/02/2012-08/23/2012) occurred until the minimum number of participants (n=80) had been enrolled.', 'preAssignmentDetails': 'A one week baseline period was to be completed before participants were randomized to intervention arms. Participants that failed to complete study requirements during this period were withdrawn due to noncompliance.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '81', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.\n\nPlacebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.'}, {'id': 'BG001', 'title': 'B. Subtilis R0179 (0.1 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}, {'id': 'BG002', 'title': 'B. Subtilis R0179 (1 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}, {'id': 'BG003', 'title': 'B. Subtilis R0179 (10 Billion CFU)', 'description': 'B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.\n\nB. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '81', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '46'}, {'value': '23', 'groupId': 'BG001', 'lowerLimit': '20', 'upperLimit': '49'}, {'value': '22', 'groupId': 'BG002', 'lowerLimit': '20', 'upperLimit': '31'}, {'value': '23', 'groupId': 'BG003', 'lowerLimit': '19', 'upperLimit': '46'}, {'value': '23', 'groupId': 'BG004', 'lowerLimit': '19', 'upperLimit': '49'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '81', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI Percentiles', 'classes': [{'title': '<85th % (Healthy Weight)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}]}, {'title': '85th-94th % (Overweight)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}]}, {'title': '>= 95th % (Obese)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Activity Level', 'classes': [{'categories': [{'measurements': [{'value': '185.5', 'spread': '70.9', 'groupId': 'BG000'}, {'value': '197.3', 'spread': '84.5', 'groupId': 'BG001'}, {'value': '168.3', 'spread': '74.9', 'groupId': 'BG002'}, {'value': '199.0', 'spread': '57.9', 'groupId': 'BG003'}, {'value': '185.9', 'spread': '72.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Minutes of physical activity were assessed according the Global Physical Activity Questionnaire', 'unitOfMeasure': 'mins of moderate and intense activity', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Participants who completed all study requirements were included in the baseline analysis population. 2 participants in the 1 Billion CFU group were excluded from the baseline analysis because they did not complete all study requirements.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-13', 'studyFirstSubmitDate': '2013-02-20', 'resultsFirstSubmitDate': '2015-03-30', 'studyFirstSubmitQcDate': '2013-02-27', 'lastUpdatePostDateStruct': {'date': '2015-12-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-13', 'studyFirstPostDateStruct': {'date': '2013-03-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).'}, {'measure': 'Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).'}, {'measure': 'Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).'}, {'measure': 'Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT)', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).'}, {'measure': 'Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).'}, {'measure': 'Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).'}, {'measure': 'Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).'}, {'measure': 'Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).'}, {'measure': 'Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).'}, {'measure': 'Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).'}, {'measure': 'Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Daily scores from weeks 2 - 5 were then averaged to arrive at a single value. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).'}, {'measure': 'Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Participants recorded the number of hours they slept on the daily questionnaire.'}, {'measure': 'Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires', 'timeFrame': 'Weeks 1, 5, and 6', 'description': 'Gastrointestinal Symptom Questionaires (GSRS) was administered during weeks 1, 5, and 6 of the study to evaluate gastrointestinal symptoms. The scale ranges from 1 (no discomfort at all) to 7 (very severe discomfort).'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study)', 'timeFrame': '6 weeks', 'description': 'Viability of B. subtilis R0179, recovered from stool samples, was assessed using one way ANOVA followed subsequently by Tukey-Kramer HSD when significance was reached (p\\<0.05). Data was normalized when appropriate. Data analyzed was log (CFU/g).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['probiotics', 'microbiota', 'survival', 'gastrointestinal', 'wellness'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '16102604', 'type': 'BACKGROUND', 'citation': 'Hong HA, Duc le H, Cutting SM. The use of bacterial spore formers as probiotics. FEMS Microbiol Rev. 2005 Sep;29(4):813-35. doi: 10.1016/j.femsre.2004.12.001. Epub 2004 Dec 16.'}, {'pmid': '19783474', 'type': 'BACKGROUND', 'citation': 'Oelschlaeger TA. Mechanisms of probiotic actions - A review. Int J Med Microbiol. 2010 Jan;300(1):57-62. doi: 10.1016/j.ijmm.2009.08.005. Epub 2009 Sep 23.'}, {'pmid': '33451235', 'type': 'BACKGROUND', 'citation': 'Sanders ME, Morelli L, Tompkins TA. Sporeformers as Human Probiotics: Bacillus, Sporolactobacillus, and Brevibacillus. Compr Rev Food Sci Food Saf. 2003 Jul;2(3):101-110. doi: 10.1111/j.1541-4337.2003.tb00017.x.'}, {'pmid': '18449224', 'type': 'BACKGROUND', 'citation': 'Tompkins TA, Hagen KE, Wallace TD, Fillion-Forte V. Safety evaluation of two bacterial strains used in Asian probiotic products. Can J Microbiol. 2008 May;54(5):391-400. doi: 10.1139/w08-022.'}, {'pmid': '21840798', 'type': 'BACKGROUND', 'citation': 'Tompkins TA, Xu X, Ahmarani J. A comprehensive review of post-market clinical studies performed in adults with an Asian probiotic formulation. Benef Microbes. 2010 Mar;1(1):93-106. doi: 10.3920/BM2008.1005.'}, {'pmid': '25062611', 'type': 'DERIVED', 'citation': 'Hanifi A, Culpepper T, Mai V, Anand A, Ford AL, Ukhanova M, Christman M, Tompkins TA, Dahl WJ. Evaluation of Bacillus subtilis R0179 on gastrointestinal viability and general wellness: a randomised, double-blind, placebo-controlled trial in healthy adults. Benef Microbes. 2015 Mar;6(1):19-27. doi: 10.3920/BM2014.0031.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/25062611', 'label': 'Evaluation of Bacillus subtilis R0179 on gastrointestinal viability and general wellness: a randomised, double-blind, placebo-controlled trial in healthy adults.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of three doses of the probiotic B. subtilis (Bacillus subtilis R0179) delivered in capsules on gastrointestinal and general wellness in healthy young adults, survival through the gastrointestinal tract and impact on intestinal microbes.', 'detailedDescription': 'A 6 week randomized, double blind placebo controlled trial in healthy young adults aged 18 to 50. Participants will be administered an oral dose of B. subtilis or placebo (1 capsule/day) for a period of 4 weeks. Viable counts will be measured from stool samples to assess transit survival, daily questionnaires (DQ) will be administered to assess general wellness, and gastrointestinal (GI) symptoms will be evaluated three times with the Gastrointestinal Symptom Response Scale (GSRS) questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Participants\n\n* Are 18-50 years of age\n* Are willing and able to complete the Informed Consent Form in English\n* Are willing to complete the GPAQ (Global Physical Activity Questionnaire) at baseline and during the last week of the study as well as completing the GSRS (Gastrointestinal Symptom Response Survey) questionnaire at baseline, during treatment and post treatment\n* Are currently "moderately active" as determined by the GPAQ (Global Physical Activity Questionnaire)\n* Are willing to have height and weight measured and to provide demographic information (age, race, sex)\n* Are willing to consume B. subtilis R0179 (approximate doses of 1, 10, or 0.1 billion CFU per day) or placebo for a 28 day period by capsule (1 per day)\n* Are willing to complete daily questionnaires regarding general and gastrointestinal wellness for the duration of the study\n* Are willing to provide 1 stool at baseline, 1 stool during week 4 of the treatment and 1 stool after 7 days of washout\n* Are willing to provide a social security number to receive study payment. Note: the subject can still participate if unwilling to provide social security number, but no financial reimbursement can be provided\n* Are willing to have internet access for the duration of the study\n\nExclusion Criteria: Potential Participants will be excluded if they\n\n* Do not meet the inclusion criteria\n* Are currently taking medications for constipation or diarrhea\n* Have taken antibiotics within the past four weeks prior to randomization\n* Are currently taking probiotics supplements and do not want to discontinue a minimum of two weeks prior to the study\n* Known to have or are currently being treated for any diseases or illnesses such as gastrointestinal disease (gastric ulcers, Crohn\'s, ulcerative colitis, etc.), other chronic diseases (diabetes, kidney disease, etc.) or immune-compromising diseases or conditions (HIV, AIDS, autoimmune, hepatitis, cancer, transplant patient etc.)'}, 'identificationModule': {'nctId': 'NCT01802151', 'briefTitle': 'Evaluation of Bacillus Subtilis R0179 in Healthy Young Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Evaluation of Bacillus Subtilis R0179 in Capsules on Gastrointestinal Survival, Transit Time, Gastrointestinal Symptoms, and General Wellness in Healthy Young Adults', 'orgStudyIdInfo': {'id': '177-2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'B. subtilis R0179 (10 billion CFU)', 'description': 'B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.\n\n\\* CFU (Colony Forming Unit)', 'interventionNames': ['Dietary Supplement: B. subtilis R0179']}, {'type': 'EXPERIMENTAL', 'label': 'B. subtilis R0179 (1 billion CFU)', 'description': 'B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.', 'interventionNames': ['Dietary Supplement: B. subtilis R0179']}, {'type': 'EXPERIMENTAL', 'label': 'B. subtilis R0179 (0.1 billion CFU)', 'description': 'B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.', 'interventionNames': ['Dietary Supplement: B. subtilis R0179']}], 'interventions': [{'name': 'B. subtilis R0179', 'type': 'DIETARY_SUPPLEMENT', 'description': 'B. subtilis R0179 for a period of 4 weeks. One capsule per day.', 'armGroupLabels': ['B. subtilis R0179 (0.1 billion CFU)', 'B. subtilis R0179 (1 billion CFU)', 'B. subtilis R0179 (10 billion CFU)']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Wendy J Dahl, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}, {'name': 'Bobbi Henken-Langkamp, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}, {'name': 'Volker Mai, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lallemand Human Nutrition', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}