Status:
ACTIVE_NOT_RECRUITING
Donor Selection for Faecal Microbiota Transplantation in Irritable Bowel Syndrome
Lead Sponsor:
Haukeland University Hospital
Collaborating Sponsors:
University of Bergen
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 ...
Detailed Description
Study Description Brief Summary: Five hundred patients are randomized1:1:1:1 into placebo (own feces), receiving 90 g fecal transplant from donor A, donor B or donor C. The fecal transplant is adminis...
Eligibility Criteria
Inclusion
- Patients who fulfil Rome IV criteria for the
- diagnosis of IBS.
- Patients were investigated to exclude other
- gastrointestinal organic cause(s).
- Moderate-to-severe IBS symptoms, as indicated
- by a score of ≥175 on the IBS-SSS questionnaire
Exclusion
- Pregnant, women planning pregnancy or lactating women.
- The use of antibiotics or probiotics within 1
- month prior to FMT.
- Having undergone any abdominal surgery, with
- the exception of appendectomy, cholecystectomy,
- caesarean section and hysterectomy.
- Previous treatment with FMT.
- Immunocompromised patients including those being
- treated by immunosuppressive medications.
- Patients with co-morbidity such as kidney failure,
- diabetes or chronic heart disease.
- Patients with serious psychiatric disorders
- or alcohol or drug abuse.
Key Trial Info
Start Date :
February 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2028
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06171126
Start Date
February 15 2024
End Date
August 31 2028
Last Update
September 22 2025
Active Locations (3)
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1
Haukeland University Hospital
Bergen, Vestland, Norway, 5021
2
Helse Møre og Romsdal HF
Ålesund, Norway
3
Diakonhjemmet
Oslo, Norway