Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2026-01-02 @ 1:07 AM
Study NCT ID:
NCT03538366
Status:
COMPLETED
Last Update Posted:
2019-12-19
First Post:
2018-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fecal Microbiota Transplantation for Chronic Pouchitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D019449', 'term': 'Pouchitis'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D007079', 'term': 'Ileitis'}, {'id': 'D004751', 'term': 'Enteritis'}, {'id': 'D007077', 'term': 'Ileal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-17', 'studyFirstSubmitDate': '2018-05-11', 'studyFirstSubmitQcDate': '2018-05-24', 'lastUpdatePostDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cure 30 days following FMT treatment', 'timeFrame': '30 days', 'description': 'PDAI \\< 7'}], 'secondaryOutcomes': [{'measure': 'Changes of the microbiota', 'timeFrame': '30 days', 'description': 'Changes in diversity of gut microbiota after FMT assessed by Shannon index'}, {'measure': 'Clinical response 30 days after FMT treatment', 'timeFrame': '30 days', 'description': 'Decrease from baseline PDAI \\> 2 points'}, {'measure': 'Histological remission following PDAI', 'timeFrame': '30 days', 'description': 'Remission of microscopic inflammation'}, {'measure': 'Improvement of pouch function', 'timeFrame': '30 days', 'description': 'Improvement of the self-reported questionnaire'}, {'measure': 'Improvement of quality of life', 'timeFrame': '30 days', 'description': 'Improvement of the self-reported questionnaire'}, {'measure': 'Improvement of sexuality', 'timeFrame': '30 days', 'description': 'Improvement of the self-reported questionnaire'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ulcerative Colitis', 'Inflammatory bowel disease', 'Pouchitis', 'Fecal microbiota transplant', 'Fecal microbiota treatment'], 'conditions': ['Ulcerative Colitis', 'Pouchitis']}, 'referencesModule': {'references': [{'pmid': '10372273', 'type': 'BACKGROUND', 'citation': "Becker JM. Surgical therapy for ulcerative colitis and Crohn's disease. Gastroenterol Clin North Am. 1999 Jun;28(2):371-90, viii-ix. doi: 10.1016/s0889-8553(05)70061-3."}, {'pmid': '14703744', 'type': 'BACKGROUND', 'citation': 'Onaitis MW, Mantyh C. Ileal pouch-anal anastomosis for ulcerative colitis and familial adenomatous polyposis: historical development and current status. Ann Surg. 2003 Dec;238(6 Suppl):S42-8. doi: 10.1097/01.sla.0000098115.90865.16.'}, {'pmid': '16830218', 'type': 'BACKGROUND', 'citation': 'Lovegrove RE, Tilney HS, Heriot AG, von Roon AC, Athanasiou T, Church J, Fazio VW, Tekkis PP. A comparison of adverse events and functional outcomes after restorative proctocolectomy for familial adenomatous polyposis and ulcerative colitis. Dis Colon Rectum. 2006 Sep;49(9):1293-306. doi: 10.1007/s10350-006-0608-0.'}, {'pmid': '7958702', 'type': 'BACKGROUND', 'citation': 'Sandborn WJ. Pouchitis following ileal pouch-anal anastomosis: definition, pathogenesis, and treatment. Gastroenterology. 1994 Dec;107(6):1856-60. doi: 10.1016/0016-5085(94)90832-x. No abstract available.'}, {'pmid': '12600225', 'type': 'BACKGROUND', 'citation': 'Shen B. Diagnosis and treatment of patients with pouchitis. Drugs. 2003;63(5):453-61. doi: 10.2165/00003495-200363050-00002.'}, {'pmid': '11720319', 'type': 'BACKGROUND', 'citation': 'Shen B, Achkar JP, Lashner BA, Ormsby AH, Remzi FH, Brzezinski A, Bevins CL, Bambrick ML, Seidner DL, Fazio VW. A randomized clinical trial of ciprofloxacin and metronidazole to treat acute pouchitis. Inflamm Bowel Dis. 2001 Nov;7(4):301-5. doi: 10.1097/00054725-200111000-00004.'}, {'pmid': '15578518', 'type': 'BACKGROUND', 'citation': 'Sandborn WJ, Pardi DS. Clinical management of pouchitis. Gastroenterology. 2004 Dec;127(6):1809-14. doi: 10.1053/j.gastro.2004.10.011. No abstract available.'}, {'pmid': '21407187', 'type': 'BACKGROUND', 'citation': 'Khan KJ, Ullman TA, Ford AC, Abreu MT, Abadir A, Marshall JK, Talley NJ, Moayyedi P. Antibiotic therapy in inflammatory bowel disease: a systematic review and meta-analysis. Am J Gastroenterol. 2011 Apr;106(4):661-73. doi: 10.1038/ajg.2011.72. Epub 2011 Mar 15.'}, {'pmid': '12894016', 'type': 'BACKGROUND', 'citation': 'Tulchinsky H, Hawley PR, Nicholls J. Long-term failure after restorative proctocolectomy for ulcerative colitis. Ann Surg. 2003 Aug;238(2):229-34. doi: 10.1097/01.sla.0000082121.84763.4c.'}, {'pmid': '25110406', 'type': 'BACKGROUND', 'citation': 'Angriman I, Scarpa M, Castagliuolo I. Relationship between pouch microbiota and pouchitis following restorative proctocolectomy for ulcerative colitis. World J Gastroenterol. 2014 Aug 7;20(29):9665-74. doi: 10.3748/wjg.v20.i29.9665.'}]}, 'descriptionModule': {'briefSummary': 'Patients with chronic pouchitis are treated with fecal transplant from several unrelated, healthy donors. The treatment consists of enemas of 100 mL fecal suspension, applied for 14 consecutive days.', 'detailedDescription': 'Background:\n\nThe surgical treatment of choice for the treatment of medically refractory ulcerative colitis (UC) is restorative ileal pouch-anal anastomosis (IPAA), in which the patient retains fecal continence following colonectomy, by subsequent anastomosis of the terminal ileum and the rectum.\n\nUp to 25% of patients with UC will undergo IPAA surgery. The most common complication following the procedure is inflammation of the pouch (pouchitis), which is seen in up to 50% of patients within the first five years of surgery. Of these patients, 10-20% will develop a chronic inflammatory condition. The clinical symptoms of pouchitis include diarrhea, rectal bleeding, stomach cramps, general malaise and reduced quality of life. Endoscopic findings include mucosal edema, granulations, and ulcerations with mucosal frailty. In most cases, a causative microorganism is not identified, although infection with Clostridium difficile or Cytomegalovirus (CMV) have been reported.\n\nThe most common treatment of pouchitis is empiric antibiotics, usually quinolones and metronidazole, or a combination of both. Following complications, removal of the pouch can become a last resort, and chronic pouchitis is the leading indication for 10% of these operations.\n\nThe composition of microbes in the gut is known to be a key factor in the homeostasis of the intestine, and plays a central role in the development of CIBD. Different single microorganisms have previously been suggested as playing an important role in this development, including: Mycobacterium avium, Escherichia coli and Clostridium difficile, that all have invasive capabilities. Several studies have investigated the connection between the composition of microbes in the gut and development of pouchitis finding an increasing evidence for a link between dysbiosis and pouchitis.\n\nMethod:\n\nPatients with chronic pouchitis are treated with fecal transplants from unrelated, healthy donors. The fecal transplant is from several healthy donors. The treatments are applied as enemas of 100 ml suspension for 14 consecutive days.\n\nPrior to treatment, pouchitis activity is graded using the pouchitis disease activity index (PDAI) based on symptoms, endoscopic and histological criteria. Patients will also complete self-reported questionnaires regarding pouch function, quality of life and sexuality.\n\nPatients are evaluated using the PDAI score 30 days following treatment together with the self-reported questionnaires. Longterm follow up is evaluated up to 6 months following FMT.\n\nScreening of FMT donors:\n\n1. Questionaire regarding possible contagious infectious diseases, followed by interview with principal investigator.\n2. Blood test for: inflammatory parameters: CRP, leucocyte count, HIV 1+2 antigen, Hepatitis A, B and C, CMV, EBV and HbA1c\n3. Fecal samples:\n\n 1. Calprotectin\n 2. Pathogenic bacteria (Salmonella, Campylobacter, Yersinia, Shigella), Vibrio, toxin-producing E. coli.\n 3. Parasites, giardia spp. and cryptosporidium spp.\n 4. Adenovirus, enterovirus, parechovirus\n 5. Clostridium difficile\n 6. Vancomycin-resistent Enterococcus faecalis and Enterococcus faecium, carbapenemase-producing enterobacteria and ESBL-producing E.coli.\n\nFMT donor exclusion criteria are:\n\n* Age \\<20 or \\>65\n* BMI \\<18.5 or \\> 28.0 kg/m2\n* Known chronic inflammatory bowel disease, celiac disease, rheumatoid arthritis or other autoimmune disease, sclerosis, psoriasis, previous extensive bowel surgery\n* In the previous 6 months:\n* Diarrhea \\> 3 days in one week or bloody stools\n* Treatment with antibiotics\n* Risk of sexually transmitted disease, tattoos, piercings, travel to areas with high endemic transmission of infectious diseases or resistants microbes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* minimum 18 years old, pouch \\> 1 year\n* at least three pouchitis events in the past year\n* antibiotic treatment for pouchitis at least one time in the past year\n\nExclusion Criteria:\n\n* immunosuppression, pregnancy, detection of specific pathogens in stool'}, 'identificationModule': {'nctId': 'NCT03538366', 'briefTitle': 'Fecal Microbiota Transplantation for Chronic Pouchitis', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'Fecal Microbiota Transplantation for the Treatment of Chronic Pouchitis', 'orgStudyIdInfo': {'id': 'FMT and Pouchitis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Donor FMT', 'description': 'Fecal transplant from unrelated, healthy volunteers', 'interventionNames': ['Other: Donor FMT']}], 'interventions': [{'name': 'Donor FMT', 'type': 'OTHER', 'description': 'Fecal transplant from unrelated, healthy donors using enemas', 'armGroupLabels': ['Donor FMT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Research Unit, Department of Gastrointestinal Surgery', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'overallOfficials': [{'name': 'Ole Thorlacius-Ussing, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aalborg University Hospital, Aalborg University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, DMSc, Professor of Surgery', 'investigatorFullName': 'Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery', 'investigatorAffiliation': 'Aalborg University Hospital'}}}}