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
University of Aarhus
20 participants
Jan 23, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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.
Exclusion Criteria5
- Diagnosed bacterial infection requiring antibiotic treatment at inclusion.
- Pregnancy or breastfeeding. Pregnancy ruled out by male sex, postmenopausal women or a negative choriogonadotropin (hCG) urine test.
- Primary diarrheal disease pre-existing to the immune checkpoint inhibitor treatment, including inflammatory bowel disease.
- Unable to ingest capsules.
- Unable to understand written or oral patient information.
Interventions
Capsule FMT
Placebo capsules
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06206707