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Donor Selection for Faecal Microbiota Transplantation in Irritable Bowel Syndrome
Sponsor: Haukeland University Hospital
Summary
Five hundred patients are randomized 1:1:1:1 into placebo (own feces), or receiving 90 g fecal transplant from donor A, donor B or donor C. The fecal transplant is administered to the distal duodenum via the working channel of a gastroscope. The patients shall complete 6 questionnaires measuring symptoms, fatigue, quality of life, stool form and diet intake at the baseline and at the end point of the trial and provide a feces sample at the baseline, and at 3, 6 and 12 months after FMT. Dysbiosis and fecal bacterial profile are determined by using 16S rRNA gene PCR DNA amplification/probe hybridization covering regions V3-V9.
Official title: The Role of Donor Selection on the Outcome of Faecal Microbiota Transplantation (FMT) in Patients With Irritable Bowel Syndrome: a Multi-center Randomised, Double-blinded Placebo-controlled Study
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2024-02-15
Completion Date
2028-08-31
Last Updated
2025-09-22
Healthy Volunteers
No
Conditions
Interventions
Placebo
By gastroscopy
Faeces from donor A
By gastroscopy
Faeces from donor B
By gastroscopy
Faeces from donor C
By gastroscopy
Locations (3)
Haukeland University Hospital
Bergen, Vestland, Norway
Helse Møre og Romsdal HF
Ålesund, Norway
Diakonhjemmet
Oslo, Norway