Using fecal microbiota transplantation to treat diarrhea and colitis from cancer immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Vedolizumab to prevent ICI-related diarrhea or colitis in cancer patients

  This study tests whether vedolizumab can prevent immune checkpoint inhibitor–related diarrhea or colitis in adults with unresectable or metastatic melanoma, lung, or kidney cancer starting immunotherapy.

  Recruiting Phase 2/3 AHS Cancer Control Alberta · Calgary, Alberta and 1 other locations · NCT06337695

• Using fecal microbiota transplantation to treat diarrhea or colitis in cancer patients

  This study is testing whether a treatment using healthy gut bacteria can help cancer patients with diarrhea or colitis caused by their cancer treatment feel better.

  Recruiting Phase 1 M.D. Anderson Cancer Center · Houston, Texas · NCT04038619

• Gut health follow-along with Peachbiotic in adults

  This single-arm study tests whether Peachbiotic taken daily for 12 weeks helps adults with gut symptoms feel better.

  Recruiting Peach Perfect · Las Vegas, Nevada · NCT07927907

• Your Kidney Cancer Immunotherapy: How You Get It and If Labs Can Be At Home

  This study tests whether people with kidney cancer prefer intravenous or subcutaneous immunotherapy and whether at‑home lab draws plus telehealth visits before treatment are practical.

  Recruiting at 7 sites Phase 4 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07872553

• Impact of a climate-resilient WASH package in Karamoja schools

  This study tests a climate-resilient water, sanitation and hygiene package in severely water-insecure primary schools in Karamoja to see if it reduces diarrhea and respiratory infections and improves attendance, especially among girls.

  Recruiting Unicef · Moroto · NCT07823231

• Do home water filters improve health for people with private wells in rural Central Appalachia

  This study tests whether providing point-of-use water filters to households using well or spring water in rural Central Appalachia can reduce acute gastrointestinal illness.

  Recruiting Virginia Polytechnic Institute and State University · Johnson City, Tennessee and 1 other locations · NCT07818902

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.