Fecal Microbiota Transplantation (FMT) in the Treatment of Pouchitis

Helsinki University Central Hospital (HUCH)

Status and phase: Completed; Phase 2

Conditions: Pouchitis; Ulcerative Colitis

Treatments: Biological: Fecal microbiota transplantation; Biological: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03378921

HelsinkiFMT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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26 participants in 2 patient groups, including a placebo group

donors feces

Experimental group

Description:

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.

Treatment:

Biological: Fecal microbiota transplantation

patients own feces

Placebo Comparator group

Description:

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.

Treatment:

Biological: Placebo