FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis

NCT06206707 | Recruiting DMC

• 1 other identifier: 1-10-72-105-23
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea; Colitis; Malignant Melanoma; Kidney Cancer

Outcome Measures

Primary Outcomes (1)

• Clinical remission of immune-mediated diarrhea

  Number of patients with steroid-free resolution of diarrhea, defined as \< 3 liquid stools (Bristol \<6) per 24 hours during day 40 and 41 after the last intervention treatment.

  At 42 days after intervention treatment

Secondary Outcomes (21)

• Remission of diarrhea defined by CTCAE

  At 42 days after intervention treatment

• Remission of colitis defined by CTCAE

  At 42 days after intervention treatment

• Therapy response of FMT

  Up to 12 weeks after intervention treatment

• Number of days until CTCAE diarrhea grade 1

  Up to 12 weeks after intervention treatment

• Number of days until resolution of diarrhea

  Up to 12 weeks after intervention treatment

Study Arms (2)

Faecal microbiota transplantation (FMT)

EXPERIMENTAL

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

Procedure: Faecal Microbiota Transplantation (FMT)

Placebo

PLACEBO COMPARATOR

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

Procedure: Placebo

Interventions

Faecal Microbiota Transplantation (FMT) PROCEDURE

Capsule FMT

Also known as: Fecal Microbiota Transplantation, FMT

Faecal microbiota transplantation (FMT)

Placebo PROCEDURE

Placebo capsules

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or above.
• Histologically proven diagnosis of malignant melanoma and/or kidney cancer.
• Treatment with any immune checkpoint inhibitor (Nivolumab, Pembrolizumab, Cemiplimab, Atezolizumab, Durvalumab, Avelumab, Ipilimumab), alone or in combination, within the last 8 weeks.
• Grade 2 or higher CTCAE diarrhea, of which at least 3 stools are Bristol chart score 6-7.
• Negative PCR for enteric pathogens including C. difficile, after the onset of diarrhea.
• Signed written informed consent.

You may not qualify if:

• Pregnancy or breastfeeding. Pregnancy ruled out by male sex, postmenopausal women or a negative choriogonadotropin (hCG) urine test.
• Primary diarrheal disease pre-existing to the immune checkpoint inhibitor treatment, including inflammatory bowel disease.
• Unable to ingest capsules.
• Unable to understand written or oral patient information.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus N, 8200, Denmark

RECRUITING

Related Links

• Centre for faecal microbiota transplantation (CEFTA)

MeSH Terms

Conditions

Diarrhea; Colitis; Melanoma; Kidney Neoplasms

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Christian L Hvas, PhD

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trine L Laursen, BSc

CONTACT

+4540408207; trnlau@rm.dk

Christian L Hvas, PhD

CONTACT

+4528351839; christian.hvas@auh.rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a double-blind, placebo controlled, randomised trial

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 16, 2024
• Study Start: January 23, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Protocol: On request. Other: after study completion
• Access Criteria: Evaluated after email request, trnlau@rm.dk

Locations

DK (1)