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Fecal Microbiota Transplantation (FMT) in the Treatment of Pouchitis

NCT03378921 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2021-04-28

Study results available
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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

Interventions

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.

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.

Sponsors & Collaborators

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Anna Lepistö, PhD, MD · Department of Gastrointestinal Surgery, Helsinki University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-27
Primary Completion
2019-09-25
Completion
2019-09-25

Countries

  • Finland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03378921 on ClinicalTrials.gov