Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-29 @ 6:48 AM
Study NCT ID:
NCT01473368
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2011-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of S. Boulardii and Amoxicillin/Clavulanate on Gut Microbiota
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019980', 'term': 'Amoxicillin-Potassium Clavulanate Combination'}], 'ancestors': [{'id': 'D019818', 'term': 'Clavulanic Acid'}, {'id': 'D002969', 'term': 'Clavulanic Acids'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ckelly2@bidmc.harvard.edu', 'phone': '617-667-1272', 'title': 'Ciaran Kelly, MD', 'organization': 'Beth Israel Deacones Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Prebiotic (Saccharomyces Boulardii)', 'description': 'Saccharomyces boulardii: 500 mg, 2 times daily for 14 days', 'otherNumAtRisk': 13, 'otherNumAffected': 5, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Antibiotic (Amoxicillin Clavulanate)', 'description': 'Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days', 'otherNumAtRisk': 12, 'otherNumAffected': 6, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Combination (Prebiotic and Antibiotic)', 'description': 'Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).', 'otherNumAtRisk': 12, 'otherNumAffected': 2, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Control', 'otherNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'gastrointestinal motility disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastrointestinal sounds abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'infrequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'regurgitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'vulvovaginal rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Gastrointestinal Symptom Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prebiotic (Saccharomyces Boulardii)', 'description': 'Saccharomyces boulardii: 500 mg, 2 times daily for 14 days'}, {'id': 'OG001', 'title': 'Antibiotic (Amoxicillin Clavulanate)', 'description': 'Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days'}, {'id': 'OG002', 'title': 'Combination (Prebiotic and Antibiotic)', 'description': 'Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).'}], 'classes': [{'categories': [{'measurements': [{'value': '18.7', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '18.7', 'spread': '3.8', 'groupId': 'OG001'}, {'value': '17.3', 'spread': '2.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Control participants were not assessed at this time point.'}, {'type': 'PRIMARY', 'title': 'Gastrointestinal Symptom Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Prebiotic (Saccharomyces Boulardii)', 'description': 'Saccharomyces boulardii: 500 mg, 2 times daily for 14 days'}, {'id': 'OG001', 'title': 'Antibiotic (Amoxicillin Clavulanate)', 'description': 'Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days'}, {'id': 'OG002', 'title': 'Combination (Prebiotic and Antibiotic)', 'description': 'Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).'}, {'id': 'OG003', 'title': 'Control', 'description': 'Control group'}], 'classes': [{'categories': [{'measurements': [{'value': '23.2', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '26.9', 'spread': '14.2', 'groupId': 'OG001'}, {'value': '18.1', 'spread': '3.0', 'groupId': 'OG002'}, {'value': '19.3', 'spread': '8.1', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.026', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day 7', 'description': 'Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Gastrointestinal Symptoms Response Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Prebiotic (Saccharomyces Boulardii)', 'description': 'Saccharomyces boulardii: 500 mg, 2 times daily for 14 days'}, {'id': 'OG001', 'title': 'Antibiotic (Amoxicillin Clavulanate)', 'description': 'Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days'}, {'id': 'OG002', 'title': 'Combination (Prebiotic and Antibiotic)', 'description': 'Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).'}, {'id': 'OG003', 'title': 'Control', 'description': 'Control group'}], 'classes': [{'categories': [{'measurements': [{'value': '19.3', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '20.3', 'spread': '5.9', 'groupId': 'OG001'}, {'value': '16.8', 'spread': '1.6', 'groupId': 'OG002'}, {'value': '18.1', 'spread': '4.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14', 'description': 'Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed were those with complete data at Day 14'}, {'type': 'PRIMARY', 'title': 'Gastrointestinal Symptoms Response Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Prebiotic (Saccharomyces Boulardii)', 'description': 'Saccharomyces boulardii: 500 mg, 2 times daily for 14 days'}, {'id': 'OG001', 'title': 'Antibiotic (Amoxicillin Clavulanate)', 'description': 'Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days'}, {'id': 'OG002', 'title': 'Combination (Prebiotic and Antibiotic)', 'description': 'Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).'}, {'id': 'OG003', 'title': 'Control', 'description': 'Control group'}], 'classes': [{'categories': [{'measurements': [{'value': '19.3', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '18.4', 'spread': '5.8', 'groupId': 'OG001'}, {'value': '16.5', 'spread': '2.9', 'groupId': 'OG002'}, {'value': '15.8', 'spread': '2.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 21', 'description': 'Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed were those with complete data at Day 14'}, {'type': 'PRIMARY', 'title': 'Prevalence of Escherichia in Stool', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prebiotic (Saccharomyces Boulardii) Before Treatment', 'description': 'Before treatment\n\nSaccharomyces boulardii: 500 mg, 2 times daily for 14 days'}, {'id': 'OG001', 'title': 'Prebiotic (Saccharomyces Boulardii) During Treatment', 'description': 'During treatment\n\nSaccharomyces boulardii: 500 mg, 2 times daily for 14 days'}, {'id': 'OG002', 'title': 'Prebiotic (Saccharomyces Boulardii) After Treatment', 'description': 'After treatment\n\nSaccharomyces boulardii: 500 mg, 2 times daily for 14 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -7 to Day 21', 'description': 'Control arm was not assessed as there was no intervention for this group.\n\nBefore Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21', 'unitOfMeasure': 'percentage of total bacteria', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Prevalence of Escherichia in Stool', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Antibiotic (Amoxicillin Clavulanate) Before Treatment', 'description': 'Before treatment\n\nAmoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days'}, {'id': 'OG001', 'title': 'Antibiotic (Amoxicillin Clavulanate) During Treatment', 'description': 'During treatment\n\nAmoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days'}, {'id': 'OG002', 'title': 'Antibiotic (Amoxicillin Clavulanate) After Treatment', 'description': 'After treatment\n\nAmoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '0', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day -7 to Day 21', 'description': 'Control arm was not assessed as there was no intervention for this group.\n\nBefore Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21', 'unitOfMeasure': 'percentage of total bacteria', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Prevalence of Escherichia in Stool', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination (Prebiotic and Antibiotic) Before Treatment', 'description': 'Before treatment\n\nSaccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).'}, {'id': 'OG001', 'title': 'Combination (Prebiotic and Antibiotic) During Treatment', 'description': 'During treatment\n\nSaccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).'}, {'id': 'OG002', 'title': 'Combination (Prebiotic and Antibiotic) After Treatment', 'description': 'After treatment\n\nSaccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '0', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -7 to Day 21', 'description': 'Control arm was not assessed as there was no intervention for this group.\n\nBefore Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21', 'unitOfMeasure': 'percentage of total bacteria', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Operational Taxonomic Units', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination (Prebiotic and Antibiotic) During Treatment', 'description': 'During Treatment\n\nSaccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).'}, {'id': 'OG001', 'title': 'Combination (Prebiotic and Antibiotic) After Treatment', 'description': 'After Treatment\n\nSaccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).'}, {'id': 'OG002', 'title': 'Antibiotic (Amoxicillin Clavulanate) During Treatment', 'description': 'During Treatment\n\nAmoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days'}, {'id': 'OG003', 'title': 'Antibiotic (Amoxicillin Clavulanate) After Treatment', 'description': 'After Treatment\n\nAmoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days'}, {'id': 'OG004', 'title': 'Core Microbiome', 'description': 'Core Microbiome'}, {'id': 'OG005', 'title': 'Prebiotic (Saccharomyces Boulardii) During Treatment', 'description': 'During Treatment\n\nSaccharomyces boulardii: 500 mg, 2 times daily for 14 days'}, {'id': 'OG006', 'title': 'Prebiotic (Saccharomyces Boulardii) After Treatment', 'description': 'After Treatment\n\nSaccharomyces boulardii: 500 mg, 2 times daily for 14 days'}], 'classes': [{'categories': [{'measurements': [{'value': '449.8', 'spread': '210.1', 'groupId': 'OG000'}, {'value': '509.9', 'spread': '251.9', 'groupId': 'OG001'}, {'value': '461.1', 'spread': '228.2', 'groupId': 'OG002'}, {'value': '668.8', 'spread': '188.4', 'groupId': 'OG003'}, {'value': '730.9', 'spread': '240.4', 'groupId': 'OG004'}, {'value': '776.7', 'spread': '167.6', 'groupId': 'OG005'}, {'value': '776.7', 'spread': '749.1', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 to Day 21', 'description': 'Core Microbiome includes control samples and baseline samples (Day -7 and Day 0) for antibiotic, probiotic, and combination groups. Data for Core microbiome for individual arms are not available.\n\nBefore Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21', 'unitOfMeasure': 'units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prebiotic (Saccharomyces Boulardii)', 'description': 'Saccharomyces boulardii: 500 mg, 2 times daily for 14 days'}, {'id': 'FG001', 'title': 'Antibiotic (Amoxicillin Clavulanate)', 'description': 'Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days'}, {'id': 'FG002', 'title': 'Combination (Prebiotic and Antibiotic)', 'description': 'Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).'}, {'id': 'FG003', 'title': 'Control', 'description': 'Control group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Prebiotic (Saccharomyces Boulardii)', 'description': 'Saccharomyces boulardii: 500 mg, 2 times daily for 14 days'}, {'id': 'BG001', 'title': 'Antibiotic (Amoxicillin Clavulanate)', 'description': 'Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days'}, {'id': 'BG002', 'title': 'Combination (Prebiotic and Antibiotic)', 'description': 'Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).'}, {'id': 'BG003', 'title': 'Control', 'description': 'control group'}, {'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': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '49', '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': '31.6', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '27.4', 'spread': '6.6', 'groupId': 'BG001'}, {'value': '34.2', 'spread': '11.4', 'groupId': 'BG002'}, {'value': '27.2', 'spread': '4.3', 'groupId': 'BG003'}, {'value': '30.1', 'spread': '8.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-03', 'studyFirstSubmitDate': '2011-11-15', 'resultsFirstSubmitDate': '2016-03-30', 'studyFirstSubmitQcDate': '2011-11-16', 'lastUpdatePostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-09-06', 'studyFirstPostDateStruct': {'date': '2011-11-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastrointestinal Symptom Rating Scale', 'timeFrame': 'Day 0', 'description': 'Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms'}, {'measure': 'Gastrointestinal Symptom Rating Scale', 'timeFrame': 'Day 7', 'description': 'Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms'}, {'measure': 'Gastrointestinal Symptoms Response Score', 'timeFrame': 'Day 14', 'description': 'Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms'}, {'measure': 'Gastrointestinal Symptoms Response Scale', 'timeFrame': 'Day 21', 'description': 'Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms'}, {'measure': 'Prevalence of Escherichia in Stool', 'timeFrame': 'Day -7 to Day 21', 'description': 'Control arm was not assessed as there was no intervention for this group.\n\nBefore Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21'}, {'measure': 'Operational Taxonomic Units', 'timeFrame': 'Day 0 to Day 21', 'description': 'Core Microbiome includes control samples and baseline samples (Day -7 and Day 0) for antibiotic, probiotic, and combination groups. Data for Core microbiome for individual arms are not available.\n\nBefore Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['human Gut Microbiota', 'gut microbiota', 'gut microbiome', 'probiotic', 'antibiotic', 'antibiotic-associated diarrhea', 'intestinal bacterial overgrowth'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '30881353', 'type': 'DERIVED', 'citation': 'Kelly CP, Chong Nguyen C, Palmieri LJ, Pallav K, Dowd SE, Humbert L, Seksik P, Bado A, Coffin B, Rainteau D, Kabbani T, Duboc H. Saccharomyces boulardii CNCM I-745 Modulates the Fecal Bile Acids Metabolism During Antimicrobial Therapy in Healthy Volunteers. Front Microbiol. 2019 Mar 4;10:336. doi: 10.3389/fmicb.2019.00336. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare and contrast the effects of the probiotic Saccharomyces boulardii, the antibiotic amoxicillin/clavulanate and the combination on the gut microbiota of healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18 to 65 years (male or female)\n* Good general health\n* Able to comply with study requirements and to provide informed consent\n* For women of childbearing potential oA negative urine pregnancy test immediately prior to starting the study treatment oAgreement to comply with approved methods of contraception during the period of active study treatment (not required during follow-up)\n\nExclusion Criteria:\n\n* History of organ transplantation\n* Known chronic or recurrent systemic disorder associated with immunocompromise\n* A history of allergy or hypersensitivity to Saccharomyces boulardii, brewer's or baker's yeast, amoxicillin, penicillins, or cephalosporins\n* History of severe allergic reaction (requiring hospital admission and/or the administration of parenteral medication or associated with dyspnoea, wheezing, hypotension, loss of consciousness).\n* Oral or systemic antibacterial therapy during the 3 months prior to study enrollment\n* New prescription medications during the 4 weeks prior to study enrollment\n* Prescription, OTC medications or supplements that are known to alter gut function or microflora (i.e. acid antisecretory drugs, probiotics) during the 4 weeks prior to study enrollment\n* Active gastrointestinal disease\n* Patients with a central venous catheter\n* Patients taking antifungals or laxatives within 14 days of enrolment\n* Patients enrolled in other clinical trials within the past 60 days\n* Prior gastrointestinal surgery (apart from appendectomy or cholecystectomy)\n* History of chronic constipation with passage of fewer than 3 bowel movements per week on average\n* Any condition or personal circumstance that, in the opinion of the investigator, renders the subject unlikely or unable to comply with the full study protocol."}, 'identificationModule': {'nctId': 'NCT01473368', 'briefTitle': 'Effects of S. Boulardii and Amoxicillin/Clavulanate on Gut Microbiota', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Open Label, Randomized Pilot Study to Examine The Effects of the Probiotic Saccharomyces Boulardii, the Antibiotic Amoxicillin/Clavulanate and the Combination on the Gut Microbiota of Healthy Volunteers', 'orgStudyIdInfo': {'id': '2011P000389'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'prebiotic (Saccharomyces boulardii)', 'description': '500 mg, 2 times daily for 14 days', 'interventionNames': ['Dietary Supplement: Saccharomyces boulardii']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'antibiotic (Amoxicillin Clavulanate)', 'description': '875/125 mg 2 times daily at least 1 hour before meals for 7 days', 'interventionNames': ['Drug: Amoxicillin Clavulanate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'combination (prebiotic and antibiotic)', 'description': 'Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).', 'interventionNames': ['Dietary Supplement: Saccharomyces boulardii', 'Drug: Amoxicillin Clavulanate']}, {'type': 'NO_INTERVENTION', 'label': 'control'}], 'interventions': [{'name': 'Saccharomyces boulardii', 'type': 'DIETARY_SUPPLEMENT', 'description': '500 mg, 2 times daily for 14 days', 'armGroupLabels': ['combination (prebiotic and antibiotic)', 'prebiotic (Saccharomyces boulardii)']}, {'name': 'Amoxicillin Clavulanate', 'type': 'DRUG', 'description': '875/125 mg 2 times daily at least 1 hour before meals for 7 days', 'armGroupLabels': ['antibiotic (Amoxicillin Clavulanate)', 'combination (prebiotic and antibiotic)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Ciaran P Kelly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biocodex', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Ciaran Kelly', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}