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: 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
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
- Maintenance of remission of ulcerative colitis
- Time Frame: 52 weeks
- Endoscopic remission and Mayo-score < 2
Participating in This Clinical Trial
- • • 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
- 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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Joint Authority for Päijät-Häme Social and Health Care
- Helsinki University Central Hospital
- Provider of Information About this Clinical Study
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