Fecal Microbiota Transplantation (FMT) in the Treatment of Pouchitis

Ulcerative Colitis Clinical Trial

Official title:

Double-blinded Randomized Placebo Controlled Study: Fecal Microbiota Transplantation in the Treatment of Chronic Pouchitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03378921
• Other study ID #: HelsinkiFMT
• Status: Completed
• Phase: Phase 2
• Start date: February 27, 2018
• Est. completion date: September 25, 2019

Study information

• Verified date: April 2021
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 25, 2019
• Est. primary completion date: September 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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:

• Unable to provide informed consent
• Use of immunosuppressive or biological medication
• Use of corticosteroids
• Acute pouchitis
• Pregnancy

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Pouchitis
• Ulcerative Colitis

Intervention

Biological:
• 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.
• 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.

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	52 weeks
Secondary	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.	54 weeks