NCT06206707Recruiting
FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis
Faecal Microbiota Transplantation for Immune Checkpoint Inhibitor-mediated Diarrhea/Colitis: a Randomised, Double-blind Pilot Efficacy and Safety Study
Source: ClinicalTrials.gov · Last updated 17 Nov 2025
Brief summary (registry, in English)
The goal of this clinical trial is to determine the outcome of patients with immune checkpoint inhibitor-mediated diarrhea/colitis (IMC) treated with faecal microbiota transplantation (FMT) in a randomised, placebo-controlled trial. The aim of the present study is to assess the feasibility, pilot efficacy, and safety of FMT for patients with IMC. Participants will be treated two times with capsule FMT or placebo capsules in a 1:1 ratio. The intervention treatment will be an add-on to the patients' standard treatment for IMC. Researchers will compare the FMT-treated group to the placebo-treated group to see if FMT promotes remission of IMC.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 2 Jan 2024
- Start date
- 23 Jan 2024
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- University of Aarhus
- Diseases
- Kidney cancer, Melanoma
- NCT number
- NCT06206707
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 23 Jan 2024 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosed bacterial infection requiring antibiotic treatment at inclusion.
- Primary diarrheal disease pre-existing to the immune checkpoint inhibitor treatment, including inflammatory bowel disease.
Other
- Pregnancy or breastfeeding. Pregnancy ruled out by male sex, postmenopausal women or a negative choriogonadotropin (hCG) urine test.
- Unable to ingest capsules.
- Unable to understand written or oral patient information.
Who the study is looking for
- Age 18 years or above.
- Histologically proven diagnosis of malignant melanoma and/or kidney cancer.
- Treatment with any immune checkpoint inhibitor (Nivolumab, Pembrolizumab, Cemiplimab, Atezolizumab, Durvalumab, Avelumab, Ipilimumab), alone or in combination, within the last 8 weeks.
- Grade 2 or higher CTCAE diarrhea, of which at least 3 stools are Bristol chart score 6-7.
- Negative PCR for enteric pathogens including C. difficile, after the onset of diarrhea.
- Signed written informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.