NCT06206707 FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis
| NCT ID | NCT06206707 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Diarrhea |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-01-23 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-01-23 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Age 18 years or above. 2. Histologically proven diagnosis of malignant melanoma and/or kidney cancer. 3. Treatment with any immune checkpoint inhibitor (Nivolumab, Pembrolizumab, Cemiplimab, Atezolizumab, Durvalumab, Avelumab, Ipilimumab), alone or in combination, within the last 8 weeks. 4. Grade 2 or higher CTCAE diarrhea, of which at least 3 stools are Bristol chart score 6-7. 5. Negative PCR for enteric pathogens including C. difficile, after the onset of diarrhea. 6. Signed written informed consent. Exclusion Criteria: 1. Diagnosed bacterial infection requiring antibiotic treatment at inclusion. 2. Pregnancy or breastfeeding. Pregnancy ruled out by male sex, postmenopausal women or a negative choriogonadotropin (hCG) urine test. 3. Primary diarrheal disease pre-existing to the immune checkpoint inhibitor treatment, including inflammatory bowel disease. 4. Unable to ingest capsules. 5. Unable to understand written or oral patient information.
Contact & Investigator
Christian L Hvas, PhD
PRINCIPAL INVESTIGATOR
University of Aarhus
Frequently Asked Questions
Who can join the NCT06206707 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diarrhea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06206707 currently recruiting?
Yes, NCT06206707 is actively recruiting participants. Contact the research team at trnlau@rm.dk for enrollment information.
Where is the NCT06206707 trial being conducted?
This trial is being conducted at Aarhus N, Denmark.
Who is sponsoring the NCT06206707 clinical trial?
NCT06206707 is sponsored by University of Aarhus. The principal investigator is Christian L Hvas, PhD at University of Aarhus. The trial plans to enroll 20 participants.