Selecting Donors for Fecal Microbiota Transplant in IBS
The Role of Donor Selection on the Outcome of Faecal Microbiota Transplantation (FMT) in Patients With Irritable Bowel Syndrome: a Randomised, Placebo-controlled Study
This study is testing if fecal microbiota transplants from specific donors can help people with irritable bowel syndrome feel better compared to a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Haukeland University Hospital Academic / other |
| Locations | 3 sites (Bergen, Vestland and 2 other locations) |
| Trial ID | NCT06171126 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves 200 patients with irritable bowel syndrome (IBS) who are randomly assigned to receive either a placebo or fecal microbiota transplants from one of three selected donors. The transplants are administered via gastroscope to the distal duodenum, and patients will complete questionnaires assessing their symptoms, quality of life, and dietary intake at various points throughout the study. Additionally, fecal samples will be collected to analyze dysbiosis and bacterial profiles using advanced genetic techniques. The aim is to evaluate the effectiveness of donor selection in improving IBS symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20-50 who meet the Rome IV criteria for IBS and have moderate-to-severe symptoms.
Not a fit: Patients who are pregnant, immunocompromised, or have significant comorbidities such as kidney failure or chronic heart disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from irritable bowel syndrome.
How similar studies have performed: Previous studies on fecal microbiota transplantation have shown promising results, suggesting that this approach may be effective for IBS treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Bergen, Vestland and 2 other locations
- Haukeland University Hospital — Bergen, Vestland, Norway (Recruiting)
- Diakonhjemmet — Oslo, Norway (Recruiting)
- Helse Møre og Romsdal HF — Ålesund, Norway (Recruiting)
Study contacts
- Study coordinator: Jan G Hatlebakk, PhD
- Email: jhat@helse-bergen.no
- Phone: +47 97707817
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.