Fecal Transplantation in 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 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.


  • 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

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