Stool Transplant to Control Treatment-related Diarrhea

  • End date
    May 6, 2023
  • participants needed
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 6 June 2022


This study will test the safety, effectiveness, and feasibility of a treatment called fecal microbiota transplantation (FMT) to reduce the symptoms of ICI-related diarrhea.

Condition Fecal Microbiota Transplantation (FMT)
Treatment Fecal microbiota transplantation (FMT)
Clinical Study IdentifierNCT04883762
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on6 June 2022


Yes No Not Sure

Inclusion Criteria

≥ 18 years old
Patient has been treated with immune checkpoint inhibitors (ICI), including anti-CTLA-4, anti-PD-1 and anti-PDL-1 therapy for any malignant indication
Patient has developed diarrhea ≥ Grade 2 attributed to ICI
Patient has diarrhea ≥ Grade 2 attributed to ICI, that persists despite treatment with corticosteroids for at least 72 hours and/or at least one dose of a biologic medication, such as infliximab or vedolizumab, with symptoms that persist or recur at least 72 hours post-infusion ° If no to the above, patient has a contraindictation to immunosuppressive treatment

Exclusion Criteria

Active GI infection, including untreated viral, bacterial or fungal or alternative identified cause(s) of diarrhea
Antibiotic exposure within 48 hours prior to FMT
Expected prolonged compromised immunity indicated by at least one of the below
Known HIV infection with CD4 count <240
ANC <1000/mm3 (use of growth factors to raise ANC is acceptable)
Seronegative for EBV or CMV (i.e. EBV IgG negative or CMV IgG negative)
Contraindications to anesthesia for procedure indicated by at least one of the below
Serious cardiopulmonary comorbidities
Inability to tolerate anesthesia
Patient is pregnant
Women of childbearing potential should not have plans to became pregnant or breastfeed an infant and must agree to use a highly effective method of birth control until 2 months after treatment with FMT (e.g. barrier method, oral or parenteral contraceptives, a vasectomized partner, or abstinence from sexual intercourse)
Severe food allergies
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