Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-04-08 @ 5:02 PM
Study NCT ID:
NCT02092402
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2014-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-27', 'studyFirstSubmitDate': '2014-03-17', 'studyFirstSubmitQcDate': '2014-03-18', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of fecal microbiota transplantation on the symptoms of IBS patients using the IBS version of the gastrointestinal symptom rating scale (GSRS-IBS)', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': "Effect of fecal transplantation on IBS patients' visceral perception (Pain scores on the visual analogue scale during barostat procedure)", 'timeFrame': '2 months'}, {'measure': "Effect of fecal transplantation on IBS patients' composition of mucosal microbiota (HITChip analysis)", 'timeFrame': '2 months'}, {'measure': "Effect of fecal transplantation on IBS patients' composition of fecal microbiota (HITChip analysis)", 'timeFrame': '6 months'}, {'measure': "Effect of fecal transplantation on IBS patients' mucosal immune cell composition (lymphocyte fingerprinting using flow cytometry)", 'timeFrame': '2 months'}, {'measure': 'Effect of fecal microbiota transplantation on the symptoms of IBS patients using the IBS - severity scoring system (IBS-SSS)', 'timeFrame': '6 months'}, {'measure': 'Effect of fecal microbiota transplantation on the symptoms of IBS patients using the health-related quality of life questionnaire for IBS patients (IBS-QOL)', 'timeFrame': '6 months'}, {'measure': 'Effect of fecal microbiota transplantation on the symptoms of IBS patients using the hospital and anxiety depression scale (HADS)', 'timeFrame': '6 months'}, {'measure': 'Effect of fecal microbiota transplantation on the general health of IBS patients using the SF-36 survey', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fecal transplantation', 'microbiota transplantation', 'irritable bowel syndrome', 'IBS'], 'conditions': ['Irritable Bowel Syndrome (IBS)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of fecal microbiota transplantation (FMT) on the symptoms of irritable bowel syndrome (IBS) patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria for patients\n\n1. Signed informed consent\n2. Fulfilled Rome III diagnostic criteria for IBS, and frequency of IBS pain or discomfort for at least 2 days a week in the last 12 weeks\n3. Age: 18-65 years\n\nExclusion criteria for patients\n\n1. High proportion of butyrate-producing microbiota in fecal samples\n2. Known organic gastrointestinal disease (e.g. IBD)\n3. Previous complicated gastrointestinal surgery\n4. Non-gastrointestinal malignancy\n5. Dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation\n6. Females who are pregnant or breast-feeding\n7. Severe endometriosis\n8. Antimicrobial treatment 4 weeks prior to first screening visit\n9. Antimicrobial prophylaxis (eg. acne, urinary tract infection)\n10. Regular consumption of probiotic products 4 weeks prior to randomization\n11. Recently (within the last 3 months) diagnosed lactose intolerance\n12. Celiac disease\n13. Abuse of alcohol or drugs\n14. Any clinically significant disease/condition which in the investigator's opinion could interfere with the results of the trial\n\nInclusion criteria for donors\n\n1. Signed informed consent\n2. High-butyrate producing microbiota in fecal samples\n3. Age: 18-65 years\n\nExclusion criteria for donors\n\n1. Known organic gastrointestinal disease (e.g. IBD, IBS, chronic diarrhea or constipation)\n2. Gastrointestinal malignancy or polyposis\n3. History of major gastrointestinal surgery (e.g. gastric bypass)\n4. Eosinophilic disorders of the gastrointestinal tract\n5. Current communicable disease (e.g. upper respiratory tract infection)\n6. Known or high risk of infectious diseases such as HIV, hepatitis A, B or C\n7. Non-gastrointestinal malignancy\n8. Dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation\n9. Comorbidities such as metabolic syndrome, autoimmune diseases, allergies\n10. Chronic pain syndromes (eg. chronic fatigue syndrome, fibromyalgia)\n11. Severe or morbid obesity\n12. Use of immunosuppressive or chemotherapy agents\n13. Antimicrobial treatment or prophylaxis within the last 6 months\n14. Females who are pregnant or breast-feeding\n15. Known clinically significant abnormal laboratory values\n16. Participation in high-risk sexual behaviors\n17. Abuse of alcohol or drugs\n18. Tattoo or body piercing within the last 6 months\n19. Travel to areas with endemic diarrhea during the last 3 months\n20. Positive stool testing for C. difficile toxin, ova, parasites, Giarda antigen, cryptosporidium antigen"}, 'identificationModule': {'nctId': 'NCT02092402', 'briefTitle': 'Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Örebro University, Sweden'}, 'officialTitle': 'Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome', 'orgStudyIdInfo': {'id': '2013/180'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Fecal transplantation of own stool', 'description': 'Autologous fecal transplantation (own stool)', 'interventionNames': ['Other: Fecal transplantation']}, {'type': 'EXPERIMENTAL', 'label': 'Fecal transplantation (stool from donor)', 'description': 'Allogeneic fecal transplantation (from donor)', 'interventionNames': ['Other: Fecal transplantation']}], 'interventions': [{'name': 'Fecal transplantation', 'type': 'OTHER', 'armGroupLabels': ['Fecal transplantation (stool from donor)', 'Fecal transplantation of own stool']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70185', 'city': 'Örebro', 'country': 'Sweden', 'facility': 'University Hospital Örebro', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}], 'overallOfficials': [{'name': 'Robert J Brummer, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Örebro, Department of Gastroenterology and Örebro University, School of Health and Medical Sciences, Faculty of Medicine and Health, Örebro, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Örebro University, Sweden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Robert Brummer', 'investigatorAffiliation': 'Örebro University, Sweden'}}}}