FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Faecal Microbiota Transplantation (FMT), Placebo.
- Who it may be relevant to
- Registry conditions: Diarrhea, Colitis, Malignant Melanoma, Kidney Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Faecal Microbiota Transplantation for Immune Checkpoint Inhibitor-mediated Diarrhea/Colitis: a Randomised, Double-blind Pilot Efficacy and Safety Study
Overview
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
Interventions
- Procedure Faecal Microbiota Transplantation (FMT)
Capsule FMT - Procedure Placebo
Placebo capsules
Primary outcome measures
- Clinical remission of immune-mediated diarrhea [Time frame: At 42 days after intervention treatment]
Secondary outcome measures (12)
- Remission of diarrhea defined by CTCAE [Time frame: At 42 days after intervention treatment]
- Remission of colitis defined by CTCAE [Time frame: At 42 days after intervention treatment]
- Therapy response of FMT [Time frame: Up to 12 weeks after intervention treatment]
- Number of days until CTCAE diarrhea grade 1 [Time frame: Up to 12 weeks after intervention treatment]
- Number of days until resolution of diarrhea [Time frame: Up to 12 weeks after intervention treatment]
- Incidence of fecal microbiota transplantation (FMT)-related adverse events [Time frame: At 42 days after intervention treatment]
- Incidence of fecal microbiota transplantation (FMT)-related serious adverse events [Time frame: At 12 weeks after intervention treatment]
- Faecal microbiota composition [Time frame: Up to 6 weeks after intervention treatment]
- Gut mucosa-associated microbiome [Time frame: Up to 6 weeks after intervention treatment]
- Faecal-calprotectin [Time frame: Up to 6 weeks after intervention treatment]
- Blood immunological parameters [Time frame: Up to 6 weeks after intervention treatment]
- Hospitalisation [Time frame: Up to 12 weeks after intervention treatment]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Diagnosed bacterial infection requiring antibiotic treatment at inclusion.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Aarhus University Hospital — Aarhus N
Identifiers
NCT: NCT06206707 · 1-10-72-105-23