FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06206707
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Aarhus
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Christian L Hvas, PhD
Principal Investigator Affiliation	University of Aarhus
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Denmark
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Diarrhea, Colitis, Malignant Melanoma, Kidney Cancer
Study Website:	View Trial Website

Additional Details

As above

Arms & Interventions

Arms

Experimental: Faecal microbiota transplantation (FMT)

Patients receive two applications of capsule FMT with 3-7 days between applications.

Placebo Comparator: Placebo

Patients receive two applications of placebo capsules with 3-7 days between applications.

Interventions

Procedure: - Faecal Microbiota Transplantation (FMT)

Capsule FMT

Procedure: - Placebo

Placebo capsules

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Aarhus University Hospital, Aarhus N, Denmark

Status

Recruiting

Address

Aarhus University Hospital

Aarhus N, , 8200

Site Contact

Christian L Hvas, PhD

[email protected]

+45 28351839

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