Clinical trial NCT03378921: Fecal Microbiota Transplantation (FMT) in the Treatment of Pouchitis
Official title: Double-blinded Randomized Placebo Controlled Study: Fecal Microbiota Transplantation in the Treatment of Chronic Pouchitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pouchitis
Ulcerative Colitis
Keywords: FMT
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2017-12-20
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Remission
timeFrame: 52 weeks
Secondary outcomes:
measure: Evaluation of the Changes in Gut Microbiota
timeFrame: 54 weeks
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
Study officials:
affiliation: Department of Gastrointestinal Surgery, Helsinki University Hospital
name: Anna Lepistö, PhD, MD
role: STUDY_DIRECTOR
References:
citation: Karjalainen EK, Renkonen-Sinisalo L, Satokari R, Mustonen H, Ristimaki A, Arkkila P, Lepisto AH. Fecal Microbiota Transplantation in Chronic Pouchitis: A Randomized, Parallel, Double-Blinded Clinical Trial. Inflamm Bowel Dis. 2021 Oct 20;27(11):1766-1772. doi: 10.1093/ibd/izab001.