Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-01-19 @ 11:43 AM
Study NCT ID:
NCT01985867
Status:
COMPLETED
Last Update Posted:
2023-05-17
First Post:
2013-10-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lcr35 for Children With Functional Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wojtyniakkasia@gmail.com', 'phone': '+48 22 317 94 21', 'title': 'Katarzyna Wojtyniak', 'organization': 'The Medical University of Warsaw'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Children were recruited in an academic center specialized in the management of children with constipation. Outcomes were evaluated only based on non-validated stool diaries completed by caregivers, except for stool consistency.'}}, 'adverseEventsModule': {'timeFrame': 'during 4 weeks of the intervention', 'eventGroups': [{'id': 'EG000', 'title': 'Lactobacillus Casei Rhamnosus Lcr35', 'description': 'Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\\^8 colony forming units (CFU), twice daily, orally for 4 weeks\n\nLactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\\^8 CFU, twice daily, orally for 4 weeks)', 'otherNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks\n\nPlacebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks', 'otherNumAtRisk': 46, 'otherNumAffected': 3, 'seriousNumAtRisk': 46, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'change in the stool smell', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'abdominal pain and flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'loss of appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Success (≥3 Spontaneous Defecations Per Week With no Fecal Soiling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Casei Rhamnosus Lcr35', 'description': 'Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\\^8 colony forming units (CFU), twice daily, orally for 4 weeks\n\nLactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\\^8 CFU, twice daily, orally for 4 weeks)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks\n\nPlacebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.399', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '0.24', 'ciUpperLimit': '1.5', 'statisticalMethod': 'risk analysis (prospective)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'in the fourth week of the intervention', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stool Consistency at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Casei Rhamnosus Lcr35', 'description': 'Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\\^8 colony forming units (CFU), twice daily, orally for 4 weeks\n\nLactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\\^8 CFU, twice daily, orally for 4 weeks)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks\n\nPlacebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '4.0'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '4.0'}]}]}], 'analyses': [{'pValue': '0.589', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.7', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'during fourth week of intervention', 'description': 'Stool consistency scores were determined using the 7-point Bristol Stool Form Scale (1 for hard lumps to 7 for watery stools).\n\nFor single value median was calculated.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Defecation Frequency at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Casei Rhamnosus Lcr35', 'description': 'Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\\^8 colony forming units (CFU), twice daily, orally for 4 weeks\n\nLactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\\^8 CFU, twice daily, orally for 4 weeks)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks\n\nPlacebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '5.0'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '9.0'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0', 'ciLowerLimit': '0.5', 'ciUpperLimit': '4.0', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'during fourth week of intervention', 'description': 'For single value median was calculated.', 'unitOfMeasure': 'defecations per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fecal Soiling Episodes at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Casei Rhamnosus Lcr35', 'description': 'Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\\^8 colony forming units (CFU), twice daily, orally for 4 weeks\n\nLactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\\^8 CFU, twice daily, orally for 4 weeks)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks\n\nPlacebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}], 'analyses': [{'pValue': '0.659', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.0', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'during fourth week of intervention', 'description': 'For single value median was calculated.', 'unitOfMeasure': 'fecal soiling episodes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Defecations That Were Painful at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Casei Rhamnosus Lcr35', 'description': 'Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\\^8 colony forming units (CFU), twice daily, orally for 4 weeks\n\nLactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\\^8 CFU, twice daily, orally for 4 weeks)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks\n\nPlacebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}], 'analyses': [{'pValue': '0.790', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.0', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'during fourth weeks of intervention', 'description': 'Pain reported by child or symptoms of pain observed by parents. For single value median was calculated.', 'unitOfMeasure': 'painful defecations', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Abdominal Pain at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Casei Rhamnosus Lcr35', 'description': 'Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\\^8 colony forming units (CFU), twice daily, orally for 4 weeks\n\nLactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\\^8 CFU, twice daily, orally for 4 weeks)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks\n\nPlacebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}], 'analyses': [{'pValue': '0.698', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.0', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'during fourth weeks of intervention', 'description': 'Abdominal pain reported by child or symptoms of pain observed by parents. For single value median was calculated.', 'unitOfMeasure': 'abdominal pain episodes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Use of Laxatives', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Casei Rhamnosus Lcr35', 'description': 'Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\\^8 colony forming units (CFU), twice daily, orally for 4 weeks\n\nLactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\\^8 CFU, twice daily, orally for 4 weeks)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks\n\nPlacebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.120', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '0.9', 'ciUpperLimit': '6.2', 'statisticalMethod': 'risk analysis (prospective)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during 4 weeks of intervention', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Casei Rhamnosus Lcr35', 'description': 'Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\\^8 colony forming units (CFU), twice daily, orally for 4 weeks\n\nLactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\\^8 CFU, twice daily, orally for 4 weeks)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks\n\nPlacebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.116', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during 4 weeks of intervention', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stool Consistency at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Casei Rhamnosus Lcr35', 'description': 'Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\\^8 colony forming units (CFU), twice daily, orally for 4 weeks\n\nLactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\\^8 CFU, twice daily, orally for 4 weeks)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks\n\nPlacebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '4.0'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '4.3'}]}]}], 'analyses': [{'pValue': '0.612', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.8', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'during first week of intervention', 'description': 'Stool consistency scores were determined using the 7-point Bristol Stool Form Scale (1 for hard lumps to 7 for watery stools).\n\nFor single value median was calculated.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Defecation Frequency at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Casei Rhamnosus Lcr35', 'description': 'Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\\^8 colony forming units (CFU), twice daily, orally for 4 weeks\n\nLactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\\^8 CFU, twice daily, orally for 4 weeks)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks\n\nPlacebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '6.0'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '8.2'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '2.0', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'during first week of intervention', 'unitOfMeasure': 'defecations per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fecal Soiling Episodes at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Casei Rhamnosus Lcr35', 'description': 'Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\\^8 colony forming units (CFU), twice daily, orally for 4 weeks\n\nLactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\\^8 CFU, twice daily, orally for 4 weeks)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks\n\nPlacebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}], 'analyses': [{'pValue': '0.708', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.0', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'during first week of intervention', 'unitOfMeasure': 'fecal soiling episodes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain During Defecation at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Casei Rhamnosus Lcr35', 'description': 'Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\\^8 colony forming units (CFU), twice daily, orally for 4 weeks\n\nLactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\\^8 CFU, twice daily, orally for 4 weeks)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks\n\nPlacebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.0'}]}]}], 'analyses': [{'pValue': '0.522', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '1.0', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'during first weeks of intervention', 'description': 'Pain reported by child or symptoms of pain observed by parents. For single value median was calculated.', 'unitOfMeasure': 'painful defecations', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Abdominal Pain at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Casei Rhamnosus Lcr35', 'description': 'Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\\^8 colony forming units (CFU), twice daily, orally for 4 weeks\n\nLactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\\^8 CFU, twice daily, orally for 4 weeks)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks\n\nPlacebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}], 'analyses': [{'pValue': '0.185', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '1.0', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'during first weeks of intervention', 'description': 'Abdominal pain reported by child or symptoms of pain observed by parents. For single value median was calculated.', 'unitOfMeasure': 'abdominal pain episodes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Flatulence at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Casei Rhamnosus Lcr35', 'description': 'Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\\^8 colony forming units (CFU), twice daily, orally for 4 weeks\n\nLactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\\^8 CFU, twice daily, orally for 4 weeks)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks\n\nPlacebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}], 'analyses': [{'pValue': '0.973', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.0', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'during fourth weeks of intervention', 'description': 'Flatulence reported by child or symptoms of pain observed by parents. For single value median was calculated.', 'unitOfMeasure': 'episodes of flatulence', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Flatulence at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Casei Rhamnosus Lcr35', 'description': 'Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\\^8 colony forming units (CFU), twice daily, orally for 4 weeks\n\nLactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\\^8 CFU, twice daily, orally for 4 weeks)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks\n\nPlacebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.2'}]}]}], 'analyses': [{'pValue': '0.642', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.0', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'during first weeks of intervention', 'description': 'Flatulence reported by child or symptoms of pain observed by parents. For single value median was calculated.', 'unitOfMeasure': 'episodes of flatulence', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lactobacillus Casei Rhamnosus Lcr35', 'description': 'Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\\^8 colony forming units (CFU), twice daily, orally for 4 weeks\n\nLactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\\^8 CFU, twice daily, orally for 4 weeks)'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks\n\nPlacebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lactobacillus Casei Rhamnosus Lcr35', 'description': 'Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\\^8 colony forming units (CFU), twice daily, orally for 4 weeks\n\nLactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\\^8 CFU, twice daily, orally for 4 weeks)'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks\n\nPlacebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.7', 'spread': '12.1', 'groupId': 'BG000'}, {'value': '37.3', 'spread': '14.2', 'groupId': 'BG001'}, {'value': '38', 'spread': '13.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'month', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Poland', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age of onset of constipation', 'classes': [{'categories': [{'measurements': [{'value': '24.0', 'spread': '12.1', 'groupId': 'BG000'}, {'value': '23.5', 'spread': '12.9', 'groupId': 'BG001'}, {'value': '23.77', 'spread': '12.45', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of constipation', 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '13.8', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '14.3', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Stools per week', 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '1.6', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '1.6', 'spread': '0.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Stools per week', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Stool consistency, Bristol scale', 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '1.7', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '1.6', 'spread': '0.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The 7-point Bristol Stool Form Scale (BSFS), which refers to 7 pictures of different forms of stool, is a commonly used instrument to assess stool consistency.\n\nBristol Stool Form Scale:\n\nType 1- Separate hard lumps, like nute (hard to pass); Type 2- Sausage- shaped but lumpy; Type 3- Like a sausage but with cracks on the surface; Type 4- Like a sausage or snake, smooth and soft; Type 5- Soft blobs with clear-cut edges; Type 6- Fluffy pieces with ragged edges, a mushy stool; Type 7- Watery, no solid pieces. Entirely Liquid.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fecal soiling', 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pain during defecation', 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Withholding behavior', 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Parents assess witholding behaviour like rock back and forth while stiffening buttocks and legs, arch back, cross legs, stand on tiptoes, and wriggle or fidget, or squat or get into other unusual positions.', 'unitOfMeasure': 'Participants'}, {'title': 'Abdominal pain', 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Blood in the stool', 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous treatment for intestinal constipation', 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Rectal impaction', 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-16', 'studyFirstSubmitDate': '2013-10-30', 'resultsFirstSubmitDate': '2017-07-02', 'studyFirstSubmitQcDate': '2013-11-09', 'lastUpdatePostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-16', 'studyFirstPostDateStruct': {'date': '2013-11-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment Success (≥3 Spontaneous Defecations Per Week With no Fecal Soiling', 'timeFrame': 'in the fourth week of the intervention'}], 'secondaryOutcomes': [{'measure': 'Stool Consistency at Week 4', 'timeFrame': 'during fourth week of intervention', 'description': 'Stool consistency scores were determined using the 7-point Bristol Stool Form Scale (1 for hard lumps to 7 for watery stools).\n\nFor single value median was calculated.'}, {'measure': 'Defecation Frequency at Week 4', 'timeFrame': 'during fourth week of intervention', 'description': 'For single value median was calculated.'}, {'measure': 'Fecal Soiling Episodes at Week 4', 'timeFrame': 'during fourth week of intervention', 'description': 'For single value median was calculated.'}, {'measure': 'Number of Defecations That Were Painful at Week 4', 'timeFrame': 'during fourth weeks of intervention', 'description': 'Pain reported by child or symptoms of pain observed by parents. For single value median was calculated.'}, {'measure': 'Abdominal Pain at Week 4', 'timeFrame': 'during fourth weeks of intervention', 'description': 'Abdominal pain reported by child or symptoms of pain observed by parents. For single value median was calculated.'}, {'measure': 'Number of Participants With Use of Laxatives', 'timeFrame': 'during 4 weeks of intervention'}, {'measure': 'Number of Participants With Adverse Effects', 'timeFrame': 'during 4 weeks of intervention'}, {'measure': 'Stool Consistency at Week 1', 'timeFrame': 'during first week of intervention', 'description': 'Stool consistency scores were determined using the 7-point Bristol Stool Form Scale (1 for hard lumps to 7 for watery stools).\n\nFor single value median was calculated.'}, {'measure': 'Defecation Frequency at Week 1', 'timeFrame': 'during first week of intervention'}, {'measure': 'Fecal Soiling Episodes at Week 1', 'timeFrame': 'during first week of intervention'}, {'measure': 'Pain During Defecation at Week 1', 'timeFrame': 'during first weeks of intervention', 'description': 'Pain reported by child or symptoms of pain observed by parents. For single value median was calculated.'}, {'measure': 'Abdominal Pain at Week 1', 'timeFrame': 'during first weeks of intervention', 'description': 'Abdominal pain reported by child or symptoms of pain observed by parents. For single value median was calculated.'}, {'measure': 'Flatulence at Week 4', 'timeFrame': 'during fourth weeks of intervention', 'description': 'Flatulence reported by child or symptoms of pain observed by parents. For single value median was calculated.'}, {'measure': 'Flatulence at Week 1', 'timeFrame': 'during first weeks of intervention', 'description': 'Flatulence reported by child or symptoms of pain observed by parents. For single value median was calculated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Constipation']}, 'referencesModule': {'references': [{'pmid': '28284477', 'type': 'DERIVED', 'citation': 'Wojtyniak K, Horvath A, Dziechciarz P, Szajewska H. Lactobacillus casei rhamnosus Lcr35 in the Management of Functional Constipation in Children: A Randomized Trial. J Pediatr. 2017 May;184:101-105.e1. doi: 10.1016/j.jpeds.2017.01.068. Epub 2017 Mar 8.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the effectiveness of Lactobacillus casei rhamnosus Lcr35 administration for the treatment of functional constipation in children.', 'detailedDescription': 'Functional constipation is a common problem which affects over 3% of children. The standard treatment does not provide sustained relief of symptoms. As a consequence, there is interest in other therapeutic options. Previously, one small (n=40) randomized controlled trial (RCT) involving 27 children showed that Lactobacillus rhamnosus casei Lcr35 compared with placebo increased treatment success defined as ≥ 3 spontaneous defecations per week with no episodes of faecal soiling, increased the defecation frequency, reduced the frequency of abdominal pain, reduced the use of glycerin enemas during the four weeks of therapy, and decreased the percentage of hard stools. However, there was no difference between groups in the use of lactulose or the number of episodes of faecal soiling. Available evidence is insufficient to draw meaningful conclusion. Further studies are needed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children below 5 years of age\n* Functional constipation according to Rome III criteria i.e. 1 month of at least 2 of the following:\n\n * Two or fewer defecations per week\n * At least 1 episode per week of incontinence after the acquisition of toileting skills\n * History of excessive stool retention\n * History of painful or hard bowel movements\n * Presence of a large fecal mass in the rectum\n * History of large- diameter stools that may obstruct the toilet\n\nExclusion Criteria:\n\n* Irritable bowel syndrome\n* Mental retardation\n* Endocrine disease (e.g. hypothyroidism)\n* Organic cause of constipation (e.g. Hirschsprung disease)\n* Spinal anomalies\n* Anatomic defects of the anorectum\n* History of previous gastrointestinal surgery\n* Functional nonretentive fecal incontinence\n* Use of drugs that influence gastrointestinal motility'}, 'identificationModule': {'nctId': 'NCT01985867', 'briefTitle': 'Lcr35 for Children With Functional Constipation', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'Effectiveness of Lactobacillus Casei Rhamnosus Lcr35 in the Management of Children With Functional Constipation: a Randomized, Double-blind, Placebo- Controlled Trial.', 'orgStudyIdInfo': {'id': '1-2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lactobacillus casei rhamnosus Lcr35', 'description': 'Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\\^8 colony forming units (CFU), twice daily, orally for 4 weeks', 'interventionNames': ['Dietary Supplement: Lactobacillus casei rhamnosus Lcr35']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Lactobacillus casei rhamnosus Lcr35', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\\^8 CFU, twice daily, orally for 4 weeks)', 'armGroupLabels': ['Lactobacillus casei rhamnosus Lcr35']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01-184', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Department of Pediatrics, Medical University of Warsaw', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Hania Szajewska, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Warsaw'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Katarzyna Wojtyniak', 'investigatorAffiliation': 'Medical University of Warsaw'}}}}