Ulcerative Colitis
Conditions
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.
Interventions
OTHERFecal microbiota transplantation (FMT)
FMT administered into the cecum of the patient in colonoscopy.
OTHERPlacebo
Autologous FMT (fecal suspension made of patients own feces) administered into the cecum of the patient in colonoscopy.
Sponsors
Helsinki University Central Hospital
University of Helsinki
Joint Authority for Päijät-Häme Social and Health Care
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The participant and the treating personnel are blinded of the randomization result.
Intervention model description
Participants are randomized in two groups to receive in colonoscopy either a fecal suspension made of their own feces or a fecal suspension of a healthy donor.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance of remission of ulcerative colitis | 52 weeks | Endoscopic remission and Mayo-score \< 2 |
Countries
Finland
Outcome results
None listed