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ACTIVE NOT RECRUITING
NCT06171126
NA

Donor Selection for Faecal Microbiota Transplantation in Irritable Bowel Syndrome

Sponsor: Haukeland University Hospital

View on ClinicalTrials.gov

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

Interventions

DIETARY_SUPPLEMENT

Placebo

By gastroscopy

DIETARY_SUPPLEMENT

Faeces from donor A

By gastroscopy

DIETARY_SUPPLEMENT

Faeces from donor B

By gastroscopy

DIETARY_SUPPLEMENT

Faeces from donor C

By gastroscopy

Locations (3)

Haukeland University Hospital

Bergen, Vestland, Norway

Helse Møre og Romsdal HF

Ålesund, Norway

Diakonhjemmet

Oslo, Norway