Donor Selection for Faecal Microbiota Transplantation in Irritable Bowel Syndrome
Key facts
- Who runs it
- Haukeland University Hospital
- Where
- Norway3 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 500 people, planned
- Started
- 15 Feb 2024
- Expected to end
- 31 Aug 2028
- Type of study
- Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Placebo
- Faeces from donor A
- Faeces from donor B
- Faeces from donor C
- Record updated
- 22 September 2025
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Pregnant, women planning pregnancy or lactating women
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- PlaceboPlacebo, for comparison
Own faeces instilled to the small intestine during gastroscopy
- Arm ATreatment being tested
90g of faeces from Donor A is instilled to the small intestine during gastroscopy
Treatment: Faeces from donor A
- Arm BTreatment being tested
90g of faeces from Donor B is instilled to the small intestine during gastroscopy
Treatment: Faeces from donor B
- Arm CTreatment being tested
90g of faeces from Donor C is instilled to the small intestine during gastroscopy
Treatment: Faeces from donor C
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 22 September 2025