Fecal Microbiota Transplantation (FMT) in the Treatment of Pouchitis

Helsinki University Central Hospital26 enrolled

Overview

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.

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 pouchitis remains unclear. There is significant clinical evidence implicating bacteria in the pathogenesis. It has been shown that fecal microbiota transplantation (FMT) is an effective treatment for recurrent Clostridium difficile -infection. Case reports have also shown promising results of FMT in patients with inflammatory bowel disease. Currently there is no established effective treatment for chronic antibiotic dependent or refractory pouchitis. The aim of our study is to investigate the efficacy and safety of fecal transplantation in the treatment of chronic pouchitis instead of antibiotic therapy. Another aim is to evaluate phylogenetic analysis of the fecal microbiota trying to find microorganisms contributing to good results in fecal transplantation in IPAA patients. Patients receive FMTs on weeks 0 and 4. Antibiotic treatment has been stopped 36 hours before the first FMT.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Pouchitis Ulcerative Colitis

Interventions

Fecal microbiota transplantationBIOLOGICAL

Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52.

PlaceboBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Helsinki University Central Hospital

Helsinki, Finland

Outcomes

Primary Outcomes

Clinical Remission

Clinical remission at week 52. All criteria need to be met: Pouchitis Disease Activity Index \<7 and no need for antibiotic treatment for pouchitis during the follow up

Time frame: 52 weeks

Secondary Outcomes

Evaluation of the Changes in Gut Microbiota

Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52.

Time frame: 54 weeks

Data from ClinicalTrials.gov

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