Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-31 @ 9:45 PM
Study NCT ID:
NCT00945334
Status:
COMPLETED
Last Update Posted:
2015-08-10
First Post:
2009-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Neomycin and Rifaximin Plus Neomycin in Treating Methane Positive Constipation Predominant Irritable Bowel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009355', 'term': 'Neomycin'}, {'id': 'D000078262', 'term': 'Rifaximin'}], 'ancestors': [{'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chuak@cshs.org', 'phone': '3104233792', 'title': 'Mark Pimentel', 'organization': 'Cedars-Sinai Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Immediately', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': 'Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days\n\nNeomycin: 500 mg po bid for 14 days\n\nPlacebo: placebo for 14 days tid', 'otherNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2', 'description': 'Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days\n\nNeomycin: 500 mg po bid for 14 days\n\nRifaximin: 550 mg po tid', 'otherNumAtRisk': 15, 'otherNumAffected': 1, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Unwell', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Severity of Constipation in Each Arm at Week 1 After Completion of Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days\n\nNeomycin: 500 mg po bid for 14 days\n\nPlacebo: placebo for 14 days tid'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days\n\nNeomycin: 500 mg po bid for 14 days\n\nRifaximin: 550 mg po tid'}], 'classes': [{'categories': [{'measurements': [{'value': '61.2', 'spread': '24.1', 'groupId': 'OG000'}, {'value': '28.6', 'spread': '30.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Visual analog scale (VAS) score for constipation:\n\nSeverity was rated using a VAS from 0 to 100 units (with 0 = no symptom and 100 = severe symptoms).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Methane From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days\n\nNeomycin: 500 mg po bid for 14 days\n\nPlacebo: placebo for 14 days tid'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days\n\nNeomycin: 500 mg po bid for 14 days\n\nRifaximin: 550 mg po tid'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'spread': '9.739557195', 'groupId': 'OG000'}, {'value': '15', 'spread': '24.81324182', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 0) and Final Visit (Day 44)', 'description': 'Methane output was reported as methane in parts per million (ppm) on breath test:\n\nSubjects fast for 12 h prior to a breath sample. Breath samples were collected via a Quintron dual bag collecting system and analyzed using a BreathTracker SC. Output was reported as methane in parts per million (ppm) after correction for alveolar sample quality using breath CO2 concentration.', 'unitOfMeasure': 'parts per million', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in breath test methane gas levels: baseline breath test minus final breath test measurement.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1', 'description': 'Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days\n\nNeomycin: 500 mg po bid for 14 days\n\nPlacebo: placebo for 14 days tid'}, {'id': 'FG001', 'title': 'Group 2', 'description': 'Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days\n\nNeomycin: 500 mg po bid for 14 days\n\nRifaximin: 550 mg po tid'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1', 'description': 'Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days\n\nNeomycin: 500 mg po bid for 14 days\n\nPlacebo: placebo for 14 days tid'}, {'id': 'BG001', 'title': 'Group 2', 'description': 'Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days\n\nNeomycin: 500 mg po bid for 14 days\n\nRifaximin: 550 mg po tid'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.4', 'spread': '14.3', 'groupId': 'BG000'}, {'value': '45.5', 'spread': '16.9', 'groupId': 'BG001'}, {'value': '42.8', 'spread': '15.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-17', 'studyFirstSubmitDate': '2009-07-23', 'resultsFirstSubmitDate': '2015-02-25', 'studyFirstSubmitQcDate': '2009-07-23', 'lastUpdatePostDateStruct': {'date': '2015-08-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-17', 'studyFirstPostDateStruct': {'date': '2009-07-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of Constipation in Each Arm at Week 1 After Completion of Therapy', 'timeFrame': '1 year', 'description': 'Visual analog scale (VAS) score for constipation:\n\nSeverity was rated using a VAS from 0 to 100 units (with 0 = no symptom and 100 = severe symptoms).'}], 'secondaryOutcomes': [{'measure': 'Change in Methane From Baseline', 'timeFrame': 'Baseline (Day 0) and Final Visit (Day 44)', 'description': 'Methane output was reported as methane in parts per million (ppm) on breath test:\n\nSubjects fast for 12 h prior to a breath sample. Breath samples were collected via a Quintron dual bag collecting system and analyzed using a BreathTracker SC. Output was reported as methane in parts per million (ppm) after correction for alveolar sample quality using breath CO2 concentration.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Constipation predominant Irritable Bowel Syndrome'], 'conditions': ['Constipation-predominant Irritable Bowel Syndrome']}, 'referencesModule': {'references': [{'pmid': '17043337', 'type': 'BACKGROUND', 'citation': 'Pimentel M, Park S, Mirocha J, Kane SV, Kong Y. The effect of a nonabsorbed oral antibiotic (rifaximin) on the symptoms of the irritable bowel syndrome: a randomized trial. Ann Intern Med. 2006 Oct 17;145(8):557-63. doi: 10.7326/0003-4819-145-8-200610170-00004.'}, {'pmid': '16832617', 'type': 'BACKGROUND', 'citation': 'Pimentel M, Chatterjee S, Chow EJ, Park S, Kong Y. Neomycin improves constipation-predominant irritable bowel syndrome in a fashion that is dependent on the presence of methane gas: subanalysis of a double-blind randomized controlled study. Dig Dis Sci. 2006 Aug;51(8):1297-301. doi: 10.1007/s10620-006-9104-6. Epub 2006 Jul 11.'}]}, 'descriptionModule': {'briefSummary': 'In this study the investigators aim to compare the efficacy of neomycin to a combination of rifaximin and neomycin in the treatment of C-IBS subjects with methane on their breath test. This study will be conducted in collaboration with Dr. John DiBaise at the Mayo Clinic in Scottsdale, AZ and Dr. Satish Rao in Georgia Regents University in Augusta, GA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rome III positive IBS subjects (18-75 years of age)\n* Meet criteria for constipation predominant IBS symptoms including ≤ 3 complete spontaneous bowel movements per week with hard or lumpy stools.\n* Presence of detectable methane on single breath sample (≥ 3ppm).\n* If subjects are ≥ 50 years old, a colonoscopy had to have been completed within the past 5 years.\n\nExclusion Criteria:\n\n* Subjects with history of intestinal surgery (except appendectomy or cholecystectomy)\n* Recent antibiotic use (within the last 30 days)\n* Subjects with known pelvic floor dysfunction\n* Pregnancy\n* Creatinine level \\> 1.4\n* Poorly controlled/uncontrolled significant medical condition that would interfere with study procedures\n* Subjects with hearing loss and/or tinnitus\n* History of bowel obstruction\n* History of celiac disease\n* History of inflammatory bowel disease\n* Cirrhosis\n* Diabetes'}, 'identificationModule': {'nctId': 'NCT00945334', 'acronym': 'C-IBS', 'briefTitle': 'Neomycin and Rifaximin Plus Neomycin in Treating Methane Positive Constipation Predominant Irritable Bowel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Double-blind, Placebo Controlled Trial Comparing Neomycin to Rifaximin Plus Neomycin in the Treatment of Methane Positive Subjects With Constipation-predominant Irritable Bowel Syndrome', 'orgStudyIdInfo': {'id': '18709'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days', 'interventionNames': ['Drug: Neomycin', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days', 'interventionNames': ['Drug: Neomycin', 'Drug: Rifaximin']}], 'interventions': [{'name': 'Neomycin', 'type': 'DRUG', 'otherNames': ['Mycifradin', 'Neo-Tab', 'Neo-Fradin'], 'description': '500 mg po bid for 14 days', 'armGroupLabels': ['Group 1', 'Group 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo for 14 days tid', 'armGroupLabels': ['Group 1']}, {'name': 'Rifaximin', 'type': 'DRUG', 'otherNames': ['Xifaxan'], 'description': '550 mg po tid', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Health Sciences University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}], 'overallOfficials': [{'name': 'Mark Pimentel, MD, FRCP(C)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mark Pimentel, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bausch Health Americas, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director, GI Motility Program', 'investigatorFullName': 'Mark Pimentel, MD', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}