Fecal Microbiota Transplantation (FMT) in the Treatment of Pouchitis

Phase 2

Completed

Interventions: Biological: Fecal microbiota transplantation
Biological: Placebo

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 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.

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 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
donors feces	Fecal microbiota transplantation	Fecal microbiota transplantation (FMT) is performed by experienced endoscopists through flexible endoscopy into the afferent limb. The second FMT is installed via transanal catheter into the pouch 4 weeks after the first FMT.
patients own feces	Placebo	Fecal microbiota transplantation (FMT) is performed by experienced endoscopists through flexible endoscopy into the afferent limb. The second FMT is installed via transanal catheter into the pouch 4 weeks after the first FMT.

Primary Outcome Measures

Name	Time	Method
Clinical Remission	52 weeks	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

Secondary Outcome Measures

Name	Time	Method
Evaluation of the Changes in Gut Microbiota	54 weeks	Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52.