Fecal Transplantation in Ulcerative Colitis

Overview

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.

Full Title of Study: “FECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF ULCERATIVE COLITIS”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 31, 2020

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.

Interventions

  • Other: Fecal microbiota transplantation (FMT)
    • FMT administered into the cecum of the patient in colonoscopy.
  • Other: Placebo
    • Autologous FMT (fecal suspension made of patients own feces) administered into the cecum of the patient in colonoscopy.

Arms, Groups and Cohorts

  • Active Comparator: FMT
    • 50% of the participants will receive fecal suspension of a healthy donor administered in colonoscopy into the cecum
  • Placebo Comparator: Placebo
    • 50% of the participants will receive fecal suspension made of their own feces administered in colonoscopy into the cecum.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Joint Authority for Päijät-Häme Social and Health Care
  • Collaborator
    • Helsinki University Central Hospital
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.