A Pilot Study of Stool Transplant to Control Immunotherapy-Related Diarrhea


Full Title

Fecal Microbiota Transplantation (FMT) for Immune Checkpoint Inhibitor (ICI)-Related Diarrhea: A Pilot Study


Diarrhea is a possible side effect of immunotherapy with checkpoint inhibitors (drugs that take the brakes off the immune response, boosting the power of the immune system to find and kill cancer cells). In this study, researchers are assessing the value of fecal microbiota transplantation (FMT) in people with severe immunotherapy-related diarrhea.

During FMT, a liquid made from stool donated by a person with normal, healthy bacteria is infused during colonoscopy into the intestine of a person whose severe diarrhea has not responded to other treatments (such as steroids, infliximab, or vedolizumab). Doctors think that the healthy bacteria in the transplanted stool will grow and replace the unhealthy bacteria and return the intestines of the recipient to a healthy state.

Who Can Join

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have severe diarrhea related to checkpoint inhibitor immunotherapy.
  • Patients’ diarrhea must persist despite other anti-diarrheal treatments.
  • This study is for patients age 18 and older.

For more information about this study, please contact Dr. David Faleck at 212-639-3904.



Disease Status

Newly Diagnosed & Relapsed/Refractory



ClinicalTrials.gov ID