Fecal Transplantation in Ulcerative Colitis (FMT-CU)

August 14, 2019 updated by: Joint Authority for Päijät-Häme Social and Health Care

FECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF ULCERATIVE COLITIS

Adult individuals with ulcerative colitis in remission are given a single fecal microbiota transplantation (FMT) in colonoscopy. A half of the patients will receive autologous FMT as a placebo and a half will receive an FMT from a healthy donor.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

80 adult patients with ulcerative colitis (UC) will be recruited. They are randomized to receive either an autologous FMT as a placebo or FMT from a healthy donor (frozen and thawed).

The patients are followed up with fecal samples to detect microbial changes. The follow up lasts 1 year after the FMT and a follow up colonoscopy will be done 52 weeks after the FMT.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • Helsinki University Hospital
      • Lahti, Finland
        • Päijät-Häme Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • • Diagnosis of CU based on clinical, endoscopic, and histological findings.

    • Remission assessed by Mayo score (0 to 1) and F-Calpro (<100 ug/g).
    • Availability of consecutive fecal samples during one year after the diagnosis of CU.
    • Availability of blood sample to study the IBD associated genetic background
    • Compliance to attend ileocolonoscopy and FMT within 3-6 months after the diagnosis of CU and at 52 week
    • 18-75 years

Exclusion Criteria:

  • Unable to provide informed consent
  • Need for any antibiotic therapy within 3 months
  • Use of corticosteroids, immunosuppressive or biological medication at the baseline
  • Use of any probiotics
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FMT
50% of the participants will receive fecal suspension of a healthy donor administered in colonoscopy into the cecum
Other: Fecal microbiota transplantation (FMT)
FMT administered into the cecum of the patient in colonoscopy.
Placebo Comparator: Placebo
50% of the participants will receive fecal suspension made of their own feces administered in colonoscopy into the cecum.
Other: Placebo
Autologous FMT (fecal suspension made of patients own feces) administered into the cecum of the patient in colonoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maintenance of remission of ulcerative colitis
Time Frame: 52 weeks
Endoscopic remission and Mayo-score < 2
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joint Authority for Päijät-Häme Social and Health Care

Collaborators

Helsinki University Central Hospital
University of Helsinki

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Anticipated)

May 31, 2020

Study Completion (Anticipated)

May 31, 2020

Study Registration Dates

First Submitted

June 6, 2018

First Submitted That Met QC Criteria

June 17, 2018

First Posted (Actual)

June 19, 2018

Study Record Updates

Last Update Posted (Actual)

August 15, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUS / 1652/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual participant data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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