Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-01-25 @ 8:32 AM
Study NCT ID:
NCT03327051
Status:
COMPLETED
Last Update Posted:
2020-03-11
First Post:
2017-10-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gastric Acid Suppression and Probiotic Colonization
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009853', 'term': 'Omeprazole'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aidah@stanford.edu', 'phone': '650-736-5555', 'title': 'Aida Habtezion', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Omeprazole and VSL #3', 'description': 'Proton pump inhibitor (Omeprazole) and VSL #3 Probiotics', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 7, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo and VSL #3', 'description': 'Placebo and VSL #3 Probiotics', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 9, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased stool frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leg pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Relative Abundance of VSL#3 Probiotic Bacterial Strains When Ingested in the Presence or Absence of the Proton Pump Inhibitor (PPI) Omeprazole at Week 4.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omeprazole and VSL #3', 'description': 'Proton pump inhibitor (Omeprazole) and VSL #3 Probiotics'}, {'id': 'OG001', 'title': 'Placebo and VSL #3', 'description': 'Placebo and VSL #3 Probiotics'}], 'classes': [{'categories': [{'measurements': [{'value': '1.002', 'spread': '0.8403', 'groupId': 'OG000'}, {'value': '0.8186', 'spread': '0.5234', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000'], 'groupDescription': 'Within group difference between week 0 and week 4 was analyzed.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Two-way ANOVA with Bonferroni post-test was used for multi-variable analysis', 'nonInferiorityComment': 'An increase in relative abundance of VSL3 bacterial strains at week 4 compared to week 0 (baseline) is considered significant if p\\<0.05.'}, {'pValue': '>0.99', 'groupIds': ['OG001'], 'groupDescription': 'Within group difference between week 0 and week 4 was analyzed.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Two-way ANOVA with Bonferroni post-test was used for multi-variable analysis', 'nonInferiorityComment': 'An increase in relative abundance of VSL3 bacterial strains at week 4 compared to week 0 (baseline) is considered significant if p\\<0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'Relative abundance is reported as the percent of combined VSL #3 probiotic bacteria strains in the bacteria sample (S. thermophiles, B. breve, B. longum, B. infantis, L. acidophilus, L. plantarum, L. paracasei, L. delbrueckii subsp. bulgaricus) following their ingestion in the presence or absence of the gastric acid suppression drug omeprazole. Stool samples were assessed.', 'unitOfMeasure': 'percentage of abundance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who attended the week 4 visit are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Symptoms Related to VSL#3 Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omeprazole and VSL #3', 'description': 'Proton pump inhibitor (Omeprazole) and VSL #3 Probiotics'}, {'id': 'OG001', 'title': 'Placebo and VSL #3', 'description': 'Placebo and VSL #3 Probiotics'}], 'classes': [{'title': 'Bloating', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Flatulence', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 0 through Week 4', 'description': 'Participants were asked to report symptoms of gastro-intestinal discomfort experienced within the last 28 days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who attended the week 4 visit are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Relative Abundance (Mean Value) of Most Abundant Bacterial Phylum Before and After VSL#3 Probiotic Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omeprazole and VSL #3', 'description': 'Proton pump inhibitor (Omeprazole) and VSL #3 Probiotics'}, {'id': 'OG001', 'title': 'Placebo and VSL #3', 'description': 'Placebo and VSL #3 Probiotics'}], 'classes': [{'title': 'Bacteroidetes at Week 0', 'categories': [{'measurements': [{'value': '66.4', 'spread': '15.1', 'groupId': 'OG000'}, {'value': '65.6', 'spread': '11.3', 'groupId': 'OG001'}]}]}, {'title': 'Bacteroidetes at Week 4', 'categories': [{'measurements': [{'value': '66.2', 'spread': '15.0', 'groupId': 'OG000'}, {'value': '68.1', 'spread': '10.2', 'groupId': 'OG001'}]}]}, {'title': 'Firmicutes at Week 0', 'categories': [{'measurements': [{'value': '25.6', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '27.2', 'spread': '9.6', 'groupId': 'OG001'}]}]}, {'title': 'Firmicutes at Week 4', 'categories': [{'measurements': [{'value': '25.7', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '25.0', 'spread': '8.3', 'groupId': 'OG001'}]}]}, {'title': 'Proteobacteria at Week 0', 'categories': [{'measurements': [{'value': '4.1', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Proteobacteria at Week 4', 'categories': [{'measurements': [{'value': '3.12', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Actinobacteria at Week 0', 'categories': [{'measurements': [{'value': '2.5', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Actinobacteria at Week 4', 'categories': [{'measurements': [{'value': '3.7', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 and Week 4', 'description': 'From week 0 to week 4, change in the relative abundance (percentage) of most common types of bacteria phyla normally found in the lower GI track (e.g. Firmicutes, Bacteroidetes, Actinobacteria and Proteobacteria) after ingesting VSL#3 in the presence or absence of omeprazole. Stool samples are assessed.', 'unitOfMeasure': 'percentage of abundance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who attended the week 4 visit are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Peak Intensity of the Metabolite 1H-Indole-4-carbaldehyde Before and After VSL#3 Probiotic Administration (Omeprazole and VSL #3).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Omeprazole and VSL #3', 'description': 'Proton pump inhibitor (Omeprazole) and VSL #3 Probiotics'}], 'classes': [{'title': '1H-Indole-4-carbaldehyde at Week 0', 'categories': [{'measurements': [{'value': '80809.5', 'spread': '118044.6', 'groupId': 'OG000'}]}]}, {'title': '1H-Indole-4-carbaldehyde at Week 4', 'categories': [{'measurements': [{'value': '286707.9', 'spread': '567693.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 and Week 4', 'description': 'From week 0 to week 4, relative change in metabolites (e.g. short chain fatty acids, bile acid derivatives, flavonoids, amino acids) found in the GI track by mass spectrometry after ingesting VSL#3. Serum samples are assessed.\n\nMZ = mass/charge ratio; RT = retention time. MZ/RT data were obtained by mass spectrometry analysis. This is a metabolite of interest for the Omeprazole and VSL#3 group only.', 'unitOfMeasure': 'MZ/RT', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Omeprazole and VSL#3 group who attended the week 4 visit are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Peak Intensity of Metabolites of Interest Before and After VSL#3 Probiotic Administration (Placebo and VSL#3 Group).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and VSL #3', 'description': 'Placebo and VSL #3 Probiotics'}], 'classes': [{'title': '11-OXOURSOLIC ACID ACETATE at Week 0', 'categories': [{'measurements': [{'value': '95819.8', 'spread': '146506.5', 'groupId': 'OG000'}]}]}, {'title': '11-OXOURSOLIC ACID ACETATE at Week 4', 'categories': [{'measurements': [{'value': '4726.2', 'spread': '18243.3', 'groupId': 'OG000'}]}]}, {'title': 'FA(14:0) at Week 0', 'categories': [{'measurements': [{'value': '539032.9', 'spread': '519162.2', 'groupId': 'OG000'}]}]}, {'title': 'FA(14:0) at Week 4', 'categories': [{'measurements': [{'value': '249632.3', 'spread': '219622.8', 'groupId': 'OG000'}]}]}, {'title': 'Iloprost S-isomer at Week 0', 'categories': [{'measurements': [{'value': '87765.6', 'spread': '189360.0', 'groupId': 'OG000'}]}]}, {'title': 'Iloprost S-isomer at Week 4', 'categories': [{'measurements': [{'value': '22405.5', 'spread': '63899.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 and Week 4', 'description': 'From week 0 to week 4, relative change in metabolites (e.g. short chain fatty acids, bile acid derivatives, flavonoids, amino acids) found in the GI track by mass spectrometry after ingesting VSL#3. Serum samples are assessed.\n\nMZ = mass/charge ratio; RT = retention time. MZ/RT data were obtained by mass spectrometry analysis. These are metabolites of interest for the Placebo and VSL#3 group only.', 'unitOfMeasure': 'MZ/RT', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Placebo and VSL#3 group who attended the week 4 visit are included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Omeprazole and VSL #3', 'description': 'Proton pump inhibitor (Omeprazole) and VSL #3 Probiotics'}, {'id': 'FG001', 'title': 'Placebo and VSL #3', 'description': 'Placebo and VSL #3 Probiotics'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Attended Visit 2 (Week 0)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Participants attended an initial study visit at week -2, followed by a baseline visit at week 0, and a final visit at week 4.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Omeprazole and VSL #3', 'description': 'Proton pump inhibitor (Omeprazole) and VSL #3 Probiotics'}, {'id': 'BG001', 'title': 'Placebo and VSL #3', 'description': 'Placebo and VSL #3 Probiotics'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36', 'spread': '13', 'groupId': 'BG000'}, {'value': '37', 'spread': '12', 'groupId': 'BG001'}, {'value': '37', 'spread': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic / White', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic / Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'NonHispanic / White', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'NonHispanic / Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'NonHispanic / Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'NonHispanic / Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'NonHispanic / Native Hawaiian / Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Relative Abundance of Probiotic Strains', 'classes': [{'categories': [{'measurements': [{'value': '0.3653', 'spread': '0.407', 'groupId': 'BG000'}, {'value': '0.5875', 'spread': '0.5691', 'groupId': 'BG001'}, {'value': '0.4764', 'spread': '0.4907', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Relative abundance is reported as the percent of combined probiotic strains in the bacteria sample (S. thermophiles, B. breve, B. longum, B. infantis, L. acidophilus, L. plantarum, L. paracasei, L. delbrueckii subsp. bulgaricus).', 'unitOfMeasure': 'percentage of abundance', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of participants experiencing gastro-intestinal symptoms.', 'classes': [{'title': 'Bloating', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Flatulence', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were asked to report symptoms of gastro-intestinal discomfort experienced within the last 28 days.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline characteristics were collected at visit 2 (week 0). Participants who attended visit 2 are included in the analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-28', 'size': 197915, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-12-11T19:08', 'hasProtocol': True}, {'date': '2019-09-13', 'size': 108076, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-12-13T19:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-27', 'studyFirstSubmitDate': '2017-10-26', 'resultsFirstSubmitDate': '2019-12-18', 'studyFirstSubmitQcDate': '2017-10-26', 'lastUpdatePostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-18', 'studyFirstPostDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative Abundance of VSL#3 Probiotic Bacterial Strains When Ingested in the Presence or Absence of the Proton Pump Inhibitor (PPI) Omeprazole at Week 4.', 'timeFrame': 'Week 4', 'description': 'Relative abundance is reported as the percent of combined VSL #3 probiotic bacteria strains in the bacteria sample (S. thermophiles, B. breve, B. longum, B. infantis, L. acidophilus, L. plantarum, L. paracasei, L. delbrueckii subsp. bulgaricus) following their ingestion in the presence or absence of the gastric acid suppression drug omeprazole. Stool samples were assessed.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Symptoms Related to VSL#3 Treatment.', 'timeFrame': 'Week 0 through Week 4', 'description': 'Participants were asked to report symptoms of gastro-intestinal discomfort experienced within the last 28 days.'}, {'measure': 'Relative Abundance (Mean Value) of Most Abundant Bacterial Phylum Before and After VSL#3 Probiotic Administration', 'timeFrame': 'Week 0 and Week 4', 'description': 'From week 0 to week 4, change in the relative abundance (percentage) of most common types of bacteria phyla normally found in the lower GI track (e.g. Firmicutes, Bacteroidetes, Actinobacteria and Proteobacteria) after ingesting VSL#3 in the presence or absence of omeprazole. Stool samples are assessed.'}, {'measure': 'Change in Peak Intensity of the Metabolite 1H-Indole-4-carbaldehyde Before and After VSL#3 Probiotic Administration (Omeprazole and VSL #3).', 'timeFrame': 'Week 0 and Week 4', 'description': 'From week 0 to week 4, relative change in metabolites (e.g. short chain fatty acids, bile acid derivatives, flavonoids, amino acids) found in the GI track by mass spectrometry after ingesting VSL#3. Serum samples are assessed.\n\nMZ = mass/charge ratio; RT = retention time. MZ/RT data were obtained by mass spectrometry analysis. This is a metabolite of interest for the Omeprazole and VSL#3 group only.'}, {'measure': 'Change in Peak Intensity of Metabolites of Interest Before and After VSL#3 Probiotic Administration (Placebo and VSL#3 Group).', 'timeFrame': 'Week 0 and Week 4', 'description': 'From week 0 to week 4, relative change in metabolites (e.g. short chain fatty acids, bile acid derivatives, flavonoids, amino acids) found in the GI track by mass spectrometry after ingesting VSL#3. Serum samples are assessed.\n\nMZ = mass/charge ratio; RT = retention time. MZ/RT data were obtained by mass spectrometry analysis. These are metabolites of interest for the Placebo and VSL#3 group only.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Probiotics']}, 'referencesModule': {'references': [{'pmid': '35063245', 'type': 'DERIVED', 'citation': 'Singh G, Haileselassie Y, Briscoe L, Bai L, Patel A, Sanjines E, Hendler S, Singh PK, Garud NR, Limketkai BN, Habtezion A. The effect of gastric acid suppression on probiotic colonization in a double blinded randomized clinical trial. Clin Nutr ESPEN. 2022 Feb;47:70-77. doi: 10.1016/j.clnesp.2021.11.005. Epub 2021 Nov 10.'}]}, 'descriptionModule': {'briefSummary': 'Probiotics are over-the-counter dietary products with microorganisms that are generally consumed for health benefit. However, the durability of these microorganisms is unclear, particularly when they pass through the highly acidic environment of the stomach. We will test the colonization of these microorganisms among individuals who consume probiotics with and without acid suppression therapy.', 'detailedDescription': 'All activities will be related to research. Participants will be randomized to receive either over-the-counter acid suppression medication or placebo from weeks -2 through week 4. All participants will receive VSL #3 (over-the-counter probiotic) from weeks 0 through 4. Survey data, serum, and stool samples will be collected at weeks -2, 0, and 4.\n\nThe intervention medication and probiotics have a very low side effect profile and are available over the counter. All data collection methods are non-invasive.\n\nElucidation of the effects of acid suppression on probiotic colonization will allow us to better understand the utility of probiotics use by individuals on acid suppression medications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy volunteers ages 18 years and ≤ 75 years.\n* Able to visit the study Doctor's office 3 times, answer 3 questionnaires, and provide stools and blood samples.\n\nExclusion Criteria:\n\n* Gastric cancer, Barrett's esophagus cancer, any gastrointestinal condition, or soy or gluten sensitivity\n* Previous abdominal surgery\n* Currently pregnant or nursing\n* Had H. Pylori Infection\n* Diagnosed with any chronic medical condition other than hypertension or hyperlipidemia\n* Currently consuming herbs or probiotics"}, 'identificationModule': {'nctId': 'NCT03327051', 'acronym': 'PR', 'briefTitle': 'Gastric Acid Suppression and Probiotic Colonization', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'The Effect of Gastric Acid Suppression on Probiotic Colonization', 'orgStudyIdInfo': {'id': '41681'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Omeprazole and VSL #3', 'description': 'Participants will receive a proton pump inhibitor (Omeprazole) and VSL #3 Probiotics', 'interventionNames': ['Drug: Omeprazole', 'Dietary Supplement: VSL #3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo and VSL #3', 'description': 'Participants will receive placebo and VSL #3 Probiotics', 'interventionNames': ['Dietary Supplement: VSL #3', 'Drug: Placebo']}], 'interventions': [{'name': 'Omeprazole', 'type': 'DRUG', 'description': 'Proton pump inhibitor (PPI) that suppresses gastric acid secretion', 'armGroupLabels': ['Omeprazole and VSL #3']}, {'name': 'VSL #3', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Probiotics', 'armGroupLabels': ['Omeprazole and VSL #3', 'Placebo and VSL #3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo to match omeprazole', 'armGroupLabels': ['Placebo and VSL #3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Aida Habtezion, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine (Gastroenterology and Hepatology)', 'investigatorFullName': 'Aida Habtezion', 'investigatorAffiliation': 'Stanford University'}}}}