Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-01-05 @ 6:26 PM
Study NCT ID:
NCT02154867
Status:
COMPLETED
Last Update Posted:
2017-01-13
First Post:
2014-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fecal Microbial Transplantation in Treatment of Irritable Bowel Syndrome; a Double Blinded Placebo Controlled Trial.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], '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'}]}, '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': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-12', 'studyFirstSubmitDate': '2014-04-10', 'studyFirstSubmitQcDate': '2014-05-30', 'lastUpdatePostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in subjective symptom score', 'timeFrame': 'at 0 and 3 months', 'description': 'Comparison of Irritable bowel syndrome severity scoring system (IBS-SSS) grade assessment before and after fecal transplantation'}], 'secondaryOutcomes': [{'measure': 'Microbiome profile change', 'timeFrame': 'at 0, 3 and 12 months', 'description': 'Characterization of fecal microbiome by metagenomic analysis before and after intervention'}, {'measure': 'Long term effects of fecal transplantation', 'timeFrame': 'at 12 months', 'description': 'Assessment of symptom burden by IBS-SSS'}, {'measure': 'Safety of fecal transplantation in IBS', 'timeFrame': 'during study period (0-12 months)', 'description': 'Registration of any adverse events. If any serious adverse events are encountered, the study group and local ethics committee will evaluate if study should be terminated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IBS-D', 'FMT', 'metagenomics', 'gut microbiome'], 'conditions': ['Irritable Bowel Syndrome']}, 'referencesModule': {'references': [{'pmid': '32991818', 'type': 'DERIVED', 'citation': 'Goll R, Johnsen PH, Hjerde E, Diab J, Valle PC, Hilpusch F, Cavanagh JP. Effects of fecal microbiota transplantation in subjects with irritable bowel syndrome are mirrored by changes in gut microbiome. Gut Microbes. 2020 Nov 9;12(1):1794263. doi: 10.1080/19490976.2020.1794263.'}, {'pmid': '29100842', 'type': 'DERIVED', 'citation': 'Johnsen PH, Hilpusch F, Cavanagh JP, Leikanger IS, Kolstad C, Valle PC, Goll R. Faecal microbiota transplantation versus placebo for moderate-to-severe irritable bowel syndrome: a double-blind, randomised, placebo-controlled, parallel-group, single-centre trial. Lancet Gastroenterol Hepatol. 2018 Jan;3(1):17-24. doi: 10.1016/S2468-1253(17)30338-2. Epub 2017 Nov 1.'}]}, 'descriptionModule': {'briefSummary': 'Fecal Microbial Transplantation in Treatment of Irritable Bowel Syndrome; a Double Blinded Placebo Controlled Trial - the REFIT project\n\nIrritable bowel syndrome (IBS) is a condition characterized by variable complaints like diarrhoea, bloating and abdominal pain, and may result in considerably reduced quality of life and increased sickness absence. The prevalence of IBS in the general population may be as high as 15 per cent depending on the diagnostic criteria used. The pathophysiology of IBS is poorly understood and theories of visceral hypersensitivity, micro-inflammation and other less well founded theories have been stated. So far, no measurement or test can affirm diagnosis, but exclusion of organic diseases in combination with a typical symptom pattern according to the Rome classification can set the diagnosis.\n\nEarlier non-controlled case reports have shown a convincing effect of fecal microbial transplantation (FMT) in IBS patients. However, no placebo controlled trial has been performed in this condition. Changes in the gut microbiome may be an important factor in IBS pathogenesis. Microbiome analysis has revealed changes in microbiome composition that may trigger changes in visceral sensibility and pain perception.\n\nThe fecal microbial transplantation (FMT) procedure has been used primarily to treat clostridium difficile infections. Few minor side effects have been reported.\n\nHypothesis: IBS is caused by an imbalance of the gut microbiome that may be reset by transplanting a microbiome sample from a healthy donor.\n\nAim of study:\n\n* To test the clinical effect of FMT in patients with IBS\n* To describe the fecal microbiome in IBS patients\n* To describe changes in the fecal microbiome of IBS patients following FMT\n\nThe REFIT study will perform a randomized placebo-controlled double blinded trial of FMT on IBS according to the Rome 3 criteria. A study group of 60 IBS (diarrhoea variant) patients will recruited from general practice and allocated to active (30) or placebo (30) by block randomization. Donors will be 15 healthy volunteers with no risk behaviour and a pre-screening for communicable diseases will be performed.\n\nOutcome measures will be clinical assessment by IBS-severity scoring system (IBS-SSS) at 0, 1, 3, 6, and 12 months. Microbiome analysis will be performed by metagenomic sequencing (University of Tromsø) at 0, 3, and 12 months for patients, and at inclusion for donors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for patients:\n\n* Patients with IBS-D according to Roma 3 criteria\n\nExclusion Criteria for patients:\n\n* Immunomodulating medication\n* Nocturnal abdominal pain\n* Constant abdominal pain\n* Alarm symptoms like rectal bleeding, weight loss, nightsweats\n* Symptomatic heart/vascular/lung disease\n* Renal failure\n* Known food allergy\n* Microscopic/collagenous colitis\n* non-compliant\n* BMI \\<18\n\nInclusion criteria for donors:\n\n* healthy volunteers\n\nExclusion criteria for donors\n\n* Tattoos, imprisoning or piercing last 3 months\n* Any history of chronic diarrhoea, constipation, inflammatory bowel disease, irritable bowel disease, colorectal polyps or cancer, immunosuppression, morbid obesity, metabolic syndrome, atopica, or fatigue\n* positive test for hepatitis B, C, HIV, treponema pallidum\n* sexual high risk habits\n* antibiotic treatment in the past 3 months'}, 'identificationModule': {'nctId': 'NCT02154867', 'acronym': 'REFIT', 'briefTitle': 'Fecal Microbial Transplantation in Treatment of Irritable Bowel Syndrome; a Double Blinded Placebo Controlled Trial.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of North Norway'}, 'officialTitle': 'Recalibrating Intestinal Microflora in IBS by Fecal Transplantation', 'orgStudyIdInfo': {'id': '2013/971/REK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fecal transplantation', 'description': 'Fecal transplantation of freshly prepared feces from healthy donor. Application by colonoscope in proximal half of colon.', 'interventionNames': ['Biological: Fecal transplantation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo fecal transplantation', 'description': "Sham transplant subject's own feces. Application by colonoscope in proximal part of colon.", 'interventionNames': ['Other: Placebo fecal transplant']}], 'interventions': [{'name': 'Fecal transplantation', 'type': 'BIOLOGICAL', 'otherNames': ['Fecal microbial transplantation'], 'description': 'Preparation of flesh feces by blending in 0.9 % saline and crude filtering. The solution is applied in proximal colon of IBS patient by colonoscopy after standard bowel preparation.', 'armGroupLabels': ['Fecal transplantation']}, {'name': 'Placebo fecal transplant', 'type': 'OTHER', 'description': 'Fecal transplantation with own feces', 'armGroupLabels': ['Placebo fecal transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9406', 'city': 'Harstad', 'country': 'Norway', 'facility': 'University Hospital of North Norway', 'geoPoint': {'lat': 68.79833, 'lon': 16.54165}}], 'overallOfficials': [{'name': 'Rasmus Goll, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of North Norway'}, {'name': 'Per C Valle, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital of North Norway'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of North Norway', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}