Status:
COMPLETED
Fecal Microbiota Transplantation (FMT) in the Treatment of Pouchitis
Lead Sponsor:
Helsinki University Central Hospital
Conditions:
Pouchitis
Ulcerative Colitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The aim of our study is to investigate the efficacy and safety of fecal microbiota transplantation (FMT) in the treatment of antibiotic dependent chronic pouchitis. This is a double-blinded randomized...
Detailed Description
Pouchitis is the most common long term complication among patients with ulcerative colitis who have undergone restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA). The etiology of pouc...
Eligibility Criteria
Inclusion
- Status post of restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) for ulcerative colitis
- Pouchitis diagnosed by the symptoms and by endoscopy including histology within 6 months prior to FMT
- Need of frequent or continuous use of antibiotics or probiotics because of the chronic pouchitis
- Availability of consecutive fecal samples during one year
- Compliance to attend FMT and control pouchoscopy after 52 weeks
Exclusion
- Unable to provide informed consent
- Use of immunosuppressive or biological medication
- Use of corticosteroids
- Acute pouchitis
- Pregnancy
Key Trial Info
Start Date :
February 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2019
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03378921
Start Date
February 27 2018
End Date
September 25 2019
Last Update
April 28 2021
Active Locations (1)
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1
Helsinki University Central Hospital
Helsinki, Finland