FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis
NCT ID: NCT06206707
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-01-23
2026-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Faecal microbiota transplantation (FMT)
Patients receive two applications of capsule FMT with 3-7 days between applications.
Faecal Microbiota Transplantation (FMT)
Capsule FMT
Placebo
Patients receive two applications of placebo capsules with 3-7 days between applications.
Placebo
Placebo capsules
Interventions
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Faecal Microbiota Transplantation (FMT)
Capsule FMT
Placebo
Placebo capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Christian L Hvas, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Aarhus
Locations
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Aarhus University Hospital
Aarhus N, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Centre for faecal microbiota transplantation (CEFTA)
Other Identifiers
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1-10-72-105-23
Identifier Type: -
Identifier Source: org_study_id
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