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Donor Selection for Faecal Microbiota Transplantation in Irritable Bowel Syndrome

NCT06171126 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2025-09-22

No results posted yet for this study

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.

Conditions

  • Irritable Bowel Syndrome

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

Sponsors & Collaborators

  • University of Bergen

    collaborator OTHER

  • Haukeland University Hospital

    lead OTHER

Principal Investigators

  • Jan G Hatlebakk, PhD · Haukeland University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-15
Primary Completion
2027-12-31
Completion
2028-08-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06171126 on ClinicalTrials.gov