Spots Global Cancer Trial Database for FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis
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Trial Identification
Brief Title: FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis
Official Title: Faecal Microbiota Transplantation for Immune Checkpoint Inhibitor-mediated Diarrhea/Colitis: a Randomised, Double-blind Pilot Efficacy and Safety Study
Study ID: NCT06206707
Study Description
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.
Detailed Description: As above
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Aarhus University Hospital, Aarhus N, , Denmark
Contact Details
Name: Christian L Hvas, PhD
Affiliation: University of Aarhus
Role: PRINCIPAL_INVESTIGATOR
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