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New treatment option for Diarrhea
Official title FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis
ClinicalTrials.gov ID: NCT06206707
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus N, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus N, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.