Stool Transplant to Control Treatment-related Diarrhea

This is an interventional treatment trial for Fecal Microbiota Transplantation (FMT) focused on measuring Immune Checkpoint Inhibitor (ICI)-Related Diarrhea, 20-242 Read More

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

• Pregnancy

  • 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