Fecal Microbiota Transplantation (FMT) in the Treatment of Pouchitis

NCT03378921 | Completed Phase 2 Results

• 1 other identifier: HelsinkiFMT
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Pouchitis; Ulcerative Colitis

Keywords

FMT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of the Changes in Gut Microbiota

  54 weeks

Study Arms (2)

donors feces

EXPERIMENTAL

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.

Biological: Fecal microbiota transplantation

patients own feces

PLACEBO COMPARATOR

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.

Biological: Placebo

Interventions

Fecal microbiota transplantation 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.

donors feces

Placebo 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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki University Central Hospital

Helsinki, Finland

Location

Related Publications (1)

• 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.

  PMID: 33501942 DERIVED

MeSH Terms

Conditions

Pouchitis; Colitis, Ulcerative

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Ileitis; Enteritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Ileal Diseases; Colitis; Inflammatory Bowel Diseases; Colonic Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Essi Karjalainen
• Organization: Department of Gastrointestinal surgery, Helsinki University Hospital

essi.karjalainen@hus.fi

+358504621853

Study Officials

• Anna Lepistö, PhD, MD

  Department of Gastrointestinal Surgery, Helsinki University Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 20, 2017
• Study Start: February 27, 2018
• Primary Completion: September 25, 2019
• Study Completion: September 25, 2019
• Last Updated: April 28, 2021
• Results First Posted: April 28, 2021

Record last verified: 2021-04

Locations

FI (1)