FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Aarhus
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Faecal Microbiota Transplantation (FMT)
- Placebo
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov