Phase 2 N=26 Randomized Triple-blind Treatment

Fecal Microbiota Transplantation (FMT) in the Treatment of Pouchitis

Pouchitis · Ulcerative Colitis

Bottom Line

View on ClinicalTrials.gov: NCT03378921 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2021

Primary outcome: Primary: Clinical Remission — 4; 5 Participants — p=0.183

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Fecal microbiota transplantation (Biological); Placebo (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Helsinki University Central Hospital
Primary completion: Sep 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Clinical Remission	4; 5	0.183
SECONDARY Evaluation of the Changes in Gut Microbiota	—	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03378921). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.