Using fecal microbiota transplantation to treat diarrhea and colitis from cancer immunotherapy
Faecal Microbiota Transplantation for Immune Checkpoint Inhibitor-mediated Diarrhea/Colitis: a Randomised, Double-blind Pilot Efficacy and Safety Study
This study tests if a stool transplant can help people with melanoma or kidney cancer who are having severe diarrhea and colitis from their immunotherapy treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Drugs / interventions | Nivolumab, Pembrolizumab, Cemiplimab, Atezolizumab, Durvalumab, Avelumab, Ipilimumab |
| Locations | 1 site (Aarhus N) |
| Trial ID | NCT06206707 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of fecal microbiota transplantation (FMT) in patients experiencing diarrhea and colitis due to immune checkpoint inhibitors. Participants will be randomly assigned to receive either FMT or a placebo in addition to their standard treatment. The study will assess the feasibility, safety, and pilot efficacy of FMT in promoting remission of immune checkpoint inhibitor-mediated diarrhea and colitis. The trial will include patients with malignant melanoma and kidney cancer who have experienced significant diarrhea after recent immunotherapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of malignant melanoma or kidney cancer who have experienced grade 2 or higher diarrhea after receiving immune checkpoint inhibitors.
Not a fit: Patients with pre-existing primary diarrheal diseases or those unable to ingest capsules may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel approach to managing severe gastrointestinal side effects in cancer patients undergoing immunotherapy.
How similar studies have performed: While the use of FMT in other gastrointestinal conditions has shown promise, this specific application in immune checkpoint inhibitor-mediated diarrhea and colitis is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Aarhus N
- Aarhus University Hospital — Aarhus N, Denmark (Recruiting)
Study contacts
- Principal investigator: Christian L Hvas, PhD — University of Aarhus
- Study coordinator: Trine L Laursen, BSc
- Email: trnlau@rm.dk
- Phone: +4540408207
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.