Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2026-03-11 @ 6:06 PM
Study NCT ID:
NCT03219528
Status:
COMPLETED
Last Update Posted:
2025-04-27
First Post:
2017-07-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Longitudinal Study to Identify IBS Phenotypes Using Fecal Microbiota and Hydrogen Breath Testing
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D003967', 'term': 'Diarrhea'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078262', 'term': 'Rifaximin'}, {'id': 'D000092622', 'term': 'FODMAP Diet'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000092724', 'term': 'Elimination Diets'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'allenlee@med.umich.edu', 'phone': '734-936-4785', 'title': 'Allen Lee', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '5 weeks', 'description': 'Some participants who were randomized to an arm withdrew or were lost to follow up before receiving an intervention. The number of participants analyzed is based on a mITT analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Rifaximin', 'description': 'Rifaximin 550 mg three times daily for 14 days\n\nRifaximin 550 MG: Rifaximin 550 mg three times daily for 14 days', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 30, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low FODMAP Group', 'description': 'Low FODMAP diet for 4 weeks\n\nLow FODMAP Diet: Low FODMAP dietary intervention for 4 weeks', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 26, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness/Light-headedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain and cramping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bloating and gas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Belching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased urination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Easily sunburned', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurry Vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mucus in Stool', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Mean Daily Abdominal Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rifaximin', 'description': 'Rifaximin 550 mg three times daily for 14 days\n\nRifaximin 550 MG: Rifaximin 550 mg three times daily for 14 days'}, {'id': 'OG001', 'title': 'Low FODMAP Group', 'description': 'Low FODMAP diet for 4 weeks\n\nLow FODMAP Diet: Low FODMAP dietary intervention for 4 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.2', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '3.9', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.78', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Baseline', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.88', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Week 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 5', 'description': 'Change in mean daily abdominal pain was measured using a visual analog scale (VAS) after intervention compared with baseline. VAS was a scale of 0 to 10, with higher numbers indicating a higher degree of pain; 0 indicated no pain and 10 indicated severe pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some participants who were randomized to an arm withdrew or were lost to follow up before receiving an intervention. The number of participants analyzed at each time point is based on a modified intent to treat (mITT) analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Irritable Bowel Syndrome (IBS) Symptom Severity Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rifaximin', 'description': 'Rifaximin 550 mg three times daily for 14 days\n\nRifaximin 550 MG: Rifaximin 550 mg three times daily for 14 days'}, {'id': 'OG001', 'title': 'Low FODMAP Group', 'description': 'Low FODMAP diet for 4 weeks\n\nLow FODMAP Diet: Low FODMAP dietary intervention for 4 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '281.3', 'spread': '81.0', 'groupId': 'OG000'}, {'value': '272.0', 'spread': '65.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '209.3', 'spread': '81.8', 'groupId': 'OG000'}, {'value': '194.7', 'spread': '79.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 5', 'description': 'The IBS Symptom Severity Scale was comprised of 5 questions each of which was on a scale of 0 to 100, with higher scores indicating more severe symptoms. The total range of the scale was 0 to 500, with 0 meaning no IBS symptoms and 500 indicating severe IBS symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some participants who were randomized to an arm withdrew or were lost to follow up before receiving an intervention. The number of participants analyzed at each time point is based on a mITT analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Gastrointestinal System Ratings Scale (GSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rifaximin', 'description': 'Rifaximin 550 mg three times daily for 14 days\n\nRifaximin 550 MG: Rifaximin 550 mg three times daily for 14 days'}, {'id': 'OG001', 'title': 'Low FODMAP Group', 'description': 'Low FODMAP diet for 4 weeks\n\nLow FODMAP Diet: Low FODMAP dietary intervention for 4 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '52.0', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '52.1', 'spread': '13.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '40.7', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '40.1', 'spread': '12.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 5', 'description': 'The GSRS was a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal Pain, Indigestion, Diarrhea, and Constipation. The GSRS had a seven-point graded Likert scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. The total range of the scale is 15 to 105 with 15 meaning low symptom burden and 105 meaning high symptom burden.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some participants who were randomized to an arm withdrew or were lost to follow up before receiving an intervention. The number of participants analyzed at each time point is based on a mITT analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Stool Form', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rifaximin', 'description': 'Rifaximin 550 mg three times daily for 14 days\n\nRifaximin 550 MG: Rifaximin 550 mg three times daily for 14 days'}, {'id': 'OG001', 'title': 'Low FODMAP Group', 'description': 'Low FODMAP diet for 4 weeks\n\nLow FODMAP Diet: Low FODMAP dietary intervention for 4 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '5.0', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 5', 'description': 'The Bristol Stool Form Scale was a diagnostic tool used to assess various digestive issues based on the type and shape of stool. The total range of the scale was 1 to 7, with 1 indicating hard stool and 7 indicating liquid stool.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some participants who were randomized to an arm withdrew or were lost to follow up before receiving an intervention. The number of participants analyzed at each time point is based on a mITT analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Psychological Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rifaximin', 'description': 'Rifaximin 550 mg three times daily for 14 days\n\nRifaximin 550 MG: Rifaximin 550 mg three times daily for 14 days'}, {'id': 'OG001', 'title': 'Low FODMAP Group', 'description': 'Low FODMAP diet for 4 weeks\n\nLow FODMAP Diet: Low FODMAP dietary intervention for 4 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.6', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '6.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '6.2', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '4.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 5', 'description': 'The PHQ-9 was a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression. It is comprised of 9 questions, each ranging from 0 to 3 with higher values indicating more severe depression symptoms. The total range of the scale was 1 to 27, with 1 indicating no or minimal depression and 27 indicating severe depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some participants who were randomized to an arm withdrew or were lost to follow up before receiving an intervention. The number of participants analyzed at each time point is based on a mITT analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rifaximin', 'description': 'Rifaximin 550 mg three times daily for 14 days\n\nRifaximin 550 MG: Rifaximin 550 mg three times daily for 14 days'}, {'id': 'OG001', 'title': 'Low FODMAP Group', 'description': 'Low FODMAP diet for 4 weeks\n\nLow FODMAP Diet: Low FODMAP dietary intervention for 4 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '53.6', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '58.9', 'spread': '21.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '62.6', 'spread': '20.4', 'groupId': 'OG000'}, {'value': '67.8', 'spread': '18.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 5', 'description': 'IBS-QOL was a condition-specific instrument for assessing health-related quality of life among persons with IBS. The IBS-QOL was comprised of 34 questions, each with a 5-point scale where the higher the value indicated the higher quality of life. The total range of the scale was 0 to 100, with 0 indicating no quality of life and 100 indicating extremely good quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some participants who were randomized to an arm withdrew or were lost to follow up before receiving an intervention. The number of participants analyzed at each time point is based on a mITT analysis.'}, {'type': 'SECONDARY', 'title': '24-hour Diet Recall/Intake - Lactose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rifaximin', 'description': 'Rifaximin 550 mg three times daily for 14 days\n\nRifaximin 550 MG: Rifaximin 550 mg three times daily for 14 days'}, {'id': 'OG001', 'title': 'Low FODMAP Group', 'description': 'Low FODMAP diet for 4 weeks\n\nLow FODMAP Diet: Low FODMAP dietary intervention for 4 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.1', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '9.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '5.1', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 5', 'description': 'Participants completed entries using the Nutrition Data System for Research (NDSR), which was a Windows-based dietary analysis program designed for the collection and analyses of 24-hour dietary recalls, food records, menus, and recipes. The NDSR was incapable of collecting data on all FODMAP-type foods, aside from lactose and gluten. The results represent data from lactose as a surrogate for all other FODMAP foods.', 'unitOfMeasure': 'grams per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some participants who were randomized to an arm withdrew or were lost to follow up before receiving an intervention. The number of participants analyzed at each time point is based on a mITT analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Glucose Breath Tests', 'timeFrame': '4 weeks', 'description': 'Glucose breath tests (GBT) will be performed at baseline and repeated after intervention', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Fecal Microbiota', 'timeFrame': '4 weeks', 'description': 'Changes in fecal microbial diversity after intervention will be compared with baseline.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'PRIMARY', 'title': 'Change in Mean Daily Bloating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rifaximin', 'description': 'Rifaximin 550 mg three times daily for 14 days\n\nRifaximin 550 MG: Rifaximin 550 mg three times daily for 14 days'}, {'id': 'OG001', 'title': 'Low FODMAP Group', 'description': 'Low FODMAP diet for 4 weeks\n\nLow FODMAP Diet: Low FODMAP dietary intervention for 4 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.9', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '4.0', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.77', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Baseline', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.58', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Week 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 5', 'description': 'Change in mean daily bloating was measured using a visual analog scale (VAS) after intervention compared with baseline. VAS was a scale of 0 to 10, with higher numbers indicating a higher degree of bloating; 0 indicated no bloating and 10 indicated severe bloating.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some participants who were randomized to an arm withdrew or were lost to follow up before receiving an intervention. The number of participants analyzed at each time point is based on a mITT analysis.'}, {'type': 'SECONDARY', 'title': '24-hour Diet Recall/Intake - Gluten', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rifaximin', 'description': 'Rifaximin 550 mg three times daily for 14 days\n\nRifaximin 550 MG: Rifaximin 550 mg three times daily for 14 days'}, {'id': 'OG001', 'title': 'Low FODMAP Group', 'description': 'Low FODMAP diet for 4 weeks\n\nLow FODMAP Diet: Low FODMAP dietary intervention for 4 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.7', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '5.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '7.2', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '4.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 5', 'description': 'Participants completed entries using the Nutrition Data System for Research (NDSR), which was a Windows-based dietary analysis program designed for the collection and analyses of 24-hour dietary recalls, food records, menus, and recipes. The NDSR was incapable of collecting data on all FODMAP-type foods, aside from lactose and gluten. The results represent data from gluten as a surrogate for all other FODMAP foods.', 'unitOfMeasure': 'grams per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some participants who were randomized to an arm withdrew or were lost to follow up before receiving an intervention. The number of participants analyzed at each time point is based on a mITT analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rifaximin', 'description': 'Rifaximin 550 mg three times daily for 14 days\n\nRifaximin 550 MG: Rifaximin 550 mg three times daily for 14 days'}, {'id': 'FG001', 'title': 'Low FODMAP Group', 'description': 'Low FODMAP diet for 4 weeks\n\nLow FODMAP Diet: Low FODMAP dietary intervention for 4 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'Actual Treatment Begun', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rifaximin', 'description': 'Rifaximin 550 mg three times daily for 14 days\n\nRifaximin 550 MG: Rifaximin 550 mg three times daily for 14 days'}, {'id': 'BG001', 'title': 'Low FODMAP Group', 'description': 'Low FODMAP diet for 4 weeks\n\nLow FODMAP Diet: Low FODMAP dietary intervention for 4 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.2', 'spread': '17.9', 'groupId': 'BG000'}, {'value': '44.1', 'spread': '16.4', 'groupId': 'BG001'}, {'value': '44.1', 'spread': '17.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '29.7', 'spread': '8.72', 'groupId': 'BG000'}, {'value': '29.8', 'spread': '8.18', 'groupId': 'BG001'}, {'value': '29.8', 'spread': '8.41', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'BMI is a medical screening tool that measures the ratio of height to weight to estimate the amount of body fat a person has.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Baseline data was collected for all participants who were randomized to an arm, regardless of whether they received an intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-06', 'size': 484730, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-09T10:02', 'hasProtocol': True}, {'date': '2024-04-11', 'size': 274812, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-03-18T14:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2017-07-13', 'resultsFirstSubmitDate': '2025-02-22', 'studyFirstSubmitQcDate': '2017-07-13', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-09', 'studyFirstPostDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Glucose Breath Tests', 'timeFrame': '4 weeks', 'description': 'Glucose breath tests (GBT) will be performed at baseline and repeated after intervention'}, {'measure': 'Fecal Microbiota', 'timeFrame': '4 weeks', 'description': 'Changes in fecal microbial diversity after intervention will be compared with baseline.'}], 'primaryOutcomes': [{'measure': 'Change in Mean Daily Abdominal Pain', 'timeFrame': 'Baseline, Week 5', 'description': 'Change in mean daily abdominal pain was measured using a visual analog scale (VAS) after intervention compared with baseline. VAS was a scale of 0 to 10, with higher numbers indicating a higher degree of pain; 0 indicated no pain and 10 indicated severe pain.'}, {'measure': 'Change in Mean Daily Bloating', 'timeFrame': 'Baseline, Week 5', 'description': 'Change in mean daily bloating was measured using a visual analog scale (VAS) after intervention compared with baseline. VAS was a scale of 0 to 10, with higher numbers indicating a higher degree of bloating; 0 indicated no bloating and 10 indicated severe bloating.'}], 'secondaryOutcomes': [{'measure': 'Change in Irritable Bowel Syndrome (IBS) Symptom Severity Scale', 'timeFrame': 'Baseline, Week 5', 'description': 'The IBS Symptom Severity Scale was comprised of 5 questions each of which was on a scale of 0 to 100, with higher scores indicating more severe symptoms. The total range of the scale was 0 to 500, with 0 meaning no IBS symptoms and 500 indicating severe IBS symptoms.'}, {'measure': 'Change in Gastrointestinal System Ratings Scale (GSRS)', 'timeFrame': 'Baseline, Week 5', 'description': 'The GSRS was a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal Pain, Indigestion, Diarrhea, and Constipation. The GSRS had a seven-point graded Likert scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. The total range of the scale is 15 to 105 with 15 meaning low symptom burden and 105 meaning high symptom burden.'}, {'measure': 'Change in Stool Form', 'timeFrame': 'Baseline, Week 5', 'description': 'The Bristol Stool Form Scale was a diagnostic tool used to assess various digestive issues based on the type and shape of stool. The total range of the scale was 1 to 7, with 1 indicating hard stool and 7 indicating liquid stool.'}, {'measure': 'Change in Psychological Function', 'timeFrame': 'Baseline, Week 5', 'description': 'The PHQ-9 was a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression. It is comprised of 9 questions, each ranging from 0 to 3 with higher values indicating more severe depression symptoms. The total range of the scale was 1 to 27, with 1 indicating no or minimal depression and 27 indicating severe depression.'}, {'measure': 'Change in Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)', 'timeFrame': 'Baseline, Week 5', 'description': 'IBS-QOL was a condition-specific instrument for assessing health-related quality of life among persons with IBS. The IBS-QOL was comprised of 34 questions, each with a 5-point scale where the higher the value indicated the higher quality of life. The total range of the scale was 0 to 100, with 0 indicating no quality of life and 100 indicating extremely good quality of life.'}, {'measure': '24-hour Diet Recall/Intake - Lactose', 'timeFrame': 'Baseline, Week 5', 'description': 'Participants completed entries using the Nutrition Data System for Research (NDSR), which was a Windows-based dietary analysis program designed for the collection and analyses of 24-hour dietary recalls, food records, menus, and recipes. The NDSR was incapable of collecting data on all FODMAP-type foods, aside from lactose and gluten. The results represent data from lactose as a surrogate for all other FODMAP foods.'}, {'measure': '24-hour Diet Recall/Intake - Gluten', 'timeFrame': 'Baseline, Week 5', 'description': 'Participants completed entries using the Nutrition Data System for Research (NDSR), which was a Windows-based dietary analysis program designed for the collection and analyses of 24-hour dietary recalls, food records, menus, and recipes. The NDSR was incapable of collecting data on all FODMAP-type foods, aside from lactose and gluten. The results represent data from gluten as a surrogate for all other FODMAP foods.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Irritable Bowel Syndrome', 'Diarrhea', 'Small Intestinal Bacterial Overgrowth', 'Gut Microbiota'], 'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'Diarrhea-predominant irritable bowel syndrome (IBS-D) is a highly prevalent but poorly understood condition with limited treatment options. Current therapies, including a nonabsorbable antibiotic rifaximin or diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP), show efficacy in 50% or less of patients. In this proposal, participants with IBS-D will be randomized to receive either rifaximin or low FODMAP dietary intervention.', 'detailedDescription': 'Diarrhea-predominant irritable bowel syndrome (IBS-D) is a highly prevalent but poorly understood condition with limited treatment options. Recent evidence has established small intestinal bacterial overgrowth (SIBO) and alterations in fecal microbiota as potential etiologies in the pathogenesis of IBS-D. Current therapies, including a nonabsorbable antibiotic rifaximin or diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP), show efficacy in 50% or less of patients \\[1-4\\]. It has been postulated that limited responses to therapies may stem from failure to identify distinct subgroups in IBS-D stratified by gut microbial profiles. In this proposal, participants with IBS-D will be randomized to receive either rifaximin or low FODMAP dietary intervention. The results of fecal microbiota-derived data as well as hydrogen breath tests will then be longitudinally followed to define SIBO. These methods will be used to test the hypotheses that: (i) distinct IBS-D phenotypes can be generated by defining fecal microbial populations as well as delineating the presence or absence of SIBO; and (ii) longitudinal analyses using microbe-derived metrics and SIBO status may relate to response to treatment with rifaximin or low FODMAP dietary intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult subjects greater than or equal to 18 years of age who meet Rome IV criteria for diarrhea-predominant irritable bowel syndrome (IBS-D).\n\nPrior colonoscopy or sigmoidoscopy within the past 2 years with random colon biopsies to exclude the presence of microscopic colitis.\n\nIBS medications, including anti-depressants, will be allowed if the dose has been stable for at least 1 month before inclusion. Medications will be carefully tracked to follow any potential confounding issues.\n\nExclusion Criteria:\n\nUnderlying celiac disease, inflammatory bowel disease, or other organic disease that could explain their symptoms.\n\nSubjects with a history of GI tract surgery, except for cholecystectomy or appendectomy, will also be excluded from the study.\n\nWomen who are pregnant or breastfeeding Antibiotics taken within 3 months prior to enrollment will not be permitted. Subjects on probiotics must discontinue their use at least 1 month prior to enrollment.\n\nSubjects who have previously received formal dietary education for IBS, including a low FODMAP diet, or previously received antibiotics, including rifaximin, for treatment of IBS-D will be excluded from the study.'}, 'identificationModule': {'nctId': 'NCT03219528', 'briefTitle': 'A Longitudinal Study to Identify IBS Phenotypes Using Fecal Microbiota and Hydrogen Breath Testing', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'A Longitudinal Study to Identify IBS Phenotypes Using Fecal Microbiota and Hydrogen Breath Testing', 'orgStudyIdInfo': {'id': 'HUM129427'}, 'secondaryIdInfos': [{'id': '1K23DK124567', 'link': 'https://reporter.nih.gov/quickSearch/1K23DK124567', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Rifaximin', 'description': 'Rifaximin 550 mg three times daily for 14 days', 'interventionNames': ['Drug: Rifaximin 550 MG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low FODMAP Group', 'description': 'Low FODMAP diet for 4 weeks', 'interventionNames': ['Other: Low FODMAP Diet']}], 'interventions': [{'name': 'Rifaximin 550 MG', 'type': 'DRUG', 'description': 'Rifaximin 550 mg three times daily for 14 days', 'armGroupLabels': ['Rifaximin']}, {'name': 'Low FODMAP Diet', 'type': 'OTHER', 'description': 'Low FODMAP dietary intervention for 4 weeks', 'armGroupLabels': ['Low FODMAP Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Allen Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All investigators are aware of and agree to abide by the principles for sharing research resources, as described by NIH in "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Programs." The data generated in this study will be shared in several ways. Manuscripts will be submitted for publication in high-quality peer-reviewed journals. Findings will also be presented at relevant national meetings, including Digestive Disease Week and Association of Clinical and Translational Science.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Michigan Institute for Clinical and Health Research (MICHR)', 'class': 'UNKNOWN'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Allen Lee', 'investigatorAffiliation': 'University of Michigan'}}}}