CompletedPhase 2

Fecal Microbiota Transplantation (FMT) in the Treatment of Pouchitis

Finland26 participantsStarted 2018-02-27

Plain-language 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 placebo controlled study. 13 patients receive a fecal transplantation from the healthy tested donor and 13 patients in the control group receive their own feces.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * Unable to provide informed consent * Use of immunosuppressive or biological medication * Use of corticosteroids * Acute pouchitis * Pregnancy

What they're measuring

Clinical Remission

Timeframe: 52 weeks

Trial details

NCT IDNCT03378921

SponsorHelsinki University Central Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-09-25

Results submitted2021-04-01

View on ClinicalTrials.gov More Pouchitis trials