FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis (Immunobiome)

University of Aarhus

Status: Enrolling

Conditions: Malignant Melanoma; Diarrhea; Kidney Cancer; Colitis

Treatments: Procedure: Placebo; Procedure: Faecal Microbiota Transplantation (FMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06206707

1-10-72-105-23

Details and patient eligibility

About

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.

Full description

As above

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

20 participants in 2 patient groups, including a placebo group

Faecal microbiota transplantation (FMT)

Experimental group

Description:

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

Treatment:

Procedure: Faecal Microbiota Transplantation (FMT)

Placebo

Placebo Comparator group

Description:

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

Treatment:

Procedure: Placebo