Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-01-06 @ 2:08 AM
Study NCT ID:
NCT03078803
Status:
COMPLETED
Last Update Posted:
2022-09-07
First Post:
2017-01-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fecal Transplant for Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-02', 'studyFirstSubmitDate': '2017-01-12', 'studyFirstSubmitQcDate': '2017-03-07', 'lastUpdatePostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical and Endoscopic Remission', 'timeFrame': 'Week 8', 'description': 'Harvey Bradshaw Index \\<5 and Simple endoscopic score \\<5'}], 'secondaryOutcomes': [{'measure': 'Clinical response', 'timeFrame': 'Week 8', 'description': 'Harvey Bradshaw Index reduction by 3 points'}, {'measure': 'Clinical remission', 'timeFrame': 'Week 8', 'description': 'Harvey Bradshaw Index \\<5'}, {'measure': 'Endoscopic response', 'timeFrame': 'Week 8', 'description': 'Simple endoscopic score reduction by 50%'}, {'measure': 'Endoscopic remission', 'timeFrame': 'Week 8', 'description': 'Simple endoscopic score \\<5'}, {'measure': 'Quality of Life 1', 'timeFrame': 'Week 8', 'description': 'Mean changes in Short Inflammatory Bowel Disease Questionnaire'}, {'measure': 'Quality of Life 2', 'timeFrame': 'Week 8', 'description': 'Mean changes in Euro five dimensions questionnaire'}, {'measure': 'Quality of Life 3', 'timeFrame': 'Week 8', 'description': 'Mean changes in Work Productivity and Activity Impairment: Crohns Disease questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fecal transplant', 'inflammatory bowel disease'], 'conditions': ['Crohn Disease']}, 'referencesModule': {'references': [{'pmid': '39530534', 'type': 'DERIVED', 'citation': "Kao D, Wong K, Jijon H, Moayyedi P, Franz R, McDougall C, Hotte N, Panaccione R, Semlacher E, Kroeker KI, Peerani F, MacDonald KV, Xu H, Narula N, Turbide C, Marshall DA, Madsen KL. Preliminary Results From a Multicenter, Randomized Trial Using Fecal Microbiota Transplantation to Induce Remission in Patients With Mild-to-Moderate Crohn's Disease. Am J Gastroenterol. 2024 Nov 12;120(6):1334-1344. doi: 10.14309/ajg.0000000000003196."}]}, 'descriptionModule': {'briefSummary': "To determine the efficacy and safety of serial FMT at inducing and maintaining clinical and endoscopic response in patients with mild to moderate Crohn's disease", 'detailedDescription': "Double blind study will randomize patients with mild to moderate Crohn's 1:1 (FMT : water) stratified by disease duration and current use of biologic therapy. First FMT/placebo at week 0 by colonoscopy plus weekly FMT/placebo by capsules for 7 weeks. At week 8, a repeat colonoscopy will be done and endoscopy score repeated.\n\nResponders in FMT arm are eligible to enter open label phase to receive FMT by capsules q2 weeks.\n\nBlood, stool and urine samples, colonic biopsies will be collected. Quality of Life as measured by Short Inflammatory Bowel Disease Questionnaire, EuroQol five dimensions, and Work Productivity and Activity Impairment Questionnaire: Crohns disease and dietary intake diary collected.\n\nColonoscopies recorded and reviewed by a central reader."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mild to moderate ileal, ileo-colonic or colonic Crohns disease\n* active ileal and/or colonic disease on endoscopy with or without elevated inflammatory markers i.e. C-reactive protein \\>8mg/L, elevated fecal calprotectin \\>250 ug/g\n* If applicable, meds stable as follows: 5-ASA for 4 weeks, prednisone up to 20mg QD for 4 weeks, budesonide up to 6mg QD for 4 weeks, azathioprine, 6-MP and methotrexate for 12 weeks\n* Use of effective contraception\n\nExclusion Criteria:\n\n* Antibiotic exposure within 30 days and probiotic exposure within 14 days\n* topical inflammatory bowel disease therapy within 2 weeks\n* active perianal disease\n* requirement for concurrent antibiotic therapy\n* SES-CD score \\<5\n* severe CD HBI \\>25 or need for hospitalization\n* abdominal abscess\n* extensive colonic resection, subtotal or total colectomy\n* ileostomy, colostomy, known fixed symptomatic stenosis or complex fistulae\n* evidence of or treatment for C. difficile or other intestinal pathogen including Cytomegalovirus within 28 days\n* requiring or expected to require surgical intervention\n* history or evidence of adenomatous colonic polyps not removed\n* history of evidence of colonic dysplasia\n* active substance abuse or psychiatric problems that may interfere with study\n* chronic Hep B, C, or HIV infection\n* pregnancy or planning to become pregnant\n* upper CD\n* history of adhesions preventing colonoscopy to cecum\n* planned bowel resection within 3 mon of enrollment'}, 'identificationModule': {'nctId': 'NCT03078803', 'briefTitle': "Fecal Transplant for Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': "A Prospective Multicenter Randomized Controlled Trial Comparing Fecal Microbiota Transplantation (FMT) to Placebo in the Treatment of Mild to Moderate Crohn's Disease", 'orgStudyIdInfo': {'id': '66218'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fecal microbiota transplant', 'description': 'Transfer of healthy human gut bacteria', 'interventionNames': ['Biological: Fecal Microbiota Transplant (FMT)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Water', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Fecal Microbiota Transplant (FMT)', 'type': 'BIOLOGICAL', 'otherNames': ['FMT'], 'description': 'FMT delivered by colonoscopy and oral capsules', 'armGroupLabels': ['Fecal microbiota transplant']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Transfer of water only', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N2T9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Foothills Hospital', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 2X8', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Dina Kao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Calgary', 'class': 'OTHER'}, {'name': 'McMaster University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}