Fecal Microbiota Transplantation (FMT) in the Treatment of Pouchitis

NCT ID: NCT03378921

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-27
• Study Completion Date: 2019-09-25

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.

Conditions

Pouchitis; Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

donors feces

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.

Group Type: EXPERIMENTAL

Fecal microbiota transplantation

Intervention Type: BIOLOGICAL

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.

patients own feces

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

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.

Interventions

Fecal microbiota transplantation

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.

Intervention Type: BIOLOGICAL

Placebo

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.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Essi Karjalainen

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Lepistö, PhD, MD

Role: STUDY_DIRECTOR

Department of Gastrointestinal Surgery, Helsinki University Hospital

Locations

Helsinki University Central Hospital

Helsinki, , Finland

Countries

Finland

References

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.

Reference Type: DERIVED

PMID: 33501942 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HelsinkiFMT

Identifier Type: -

Identifier Source: org_study_id