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FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis

NCT06206707 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-11-17

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Faecal Microbiota Transplantation (FMT)

Capsule FMT

PROCEDURE

Placebo

Placebo capsules

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Christian L Hvas, PhD · University of Aarhus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-23
Primary Completion
2026-06-30
Completion
2026-10-31

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06206707 on ClinicalTrials.gov