Fecal Transplantation in Ulcerative Colitis
- Conditions
- Ulcerative Colitis
- Registration Number
- NCT03561532
- Lead Sponsor
- Joint Authority for Päijät-Häme Social and Health Care
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 48
-
• • 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
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Maintenance of remission of ulcerative colitis 52 weeks Endoscopic remission and Mayo-score \< 2
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Helsinki University Hospital
🇫🇮Helsinki, Finland
Päijät-Häme Central Hospital
🇫🇮Lahti, Finland
Helsinki University Hospital🇫🇮Helsinki, Finland