Fecal Microbiota Transplantation in Newly Diagnosed Ulcerative Colitis Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Turku University Hospital
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Modified gut microbiota composition
Study Overview
Brief Summary
In this FinUC study we are trying to find out the efficacy and safety of the Fecal microbiota transplantation (FMT) in newly diagnosed active ulcerative colitis patients. The study group with newly diagnosed active ulcerative colitis receive an FMT via colonoscopy from a tested general donor, frozen and thawed from a fecal bank at week 0 and at week 4 as an enema at the study nurse´s visit. The control group will be given colored water. The main aim of the FinUC study is to determine how the FMT change of the gut microbiota composition in newly diagnosed active ulcerative colitis patients. The other aim is to determine efficacy and mechanisms of fecal microbiota transplantation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
e
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Over 18 years
- •Active newly diagnosed colitis (Mayo score <11)
- •Signed informed consent
Exclusion Criteria
- •Fulminant severe colitis (Mayo score 11-12 or Truelove and Witts criteria)
- •Gastrointestinal infection
- •Pregnancy
- •Antibiotic therapy at the baseline
- •On-going probiotic medication
- •Unable to provide signed informed consent
Outcomes
Primary Outcomes
Modified gut microbiota composition
Time Frame: at week 12
Increased species richness and alfa-diversity
Secondary Outcomes
No secondary outcomes reported
Investigators
Kimmo Salminen
MD, PhD, Specialist in Gastroenterology
Turku University Hospital