Clinical trial NCT04883762: Stool Transplant to Control Treatment-related Diarrhea
Official title: Fecal Microbiota Transplantation (FMT) for Immune Checkpoint Inhibitor (ICI)-Related Diarrhea: A Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Fecal Microbiota Transplantation (FMT)
Keywords: Immune Checkpoint Inhibitor (ICI)-Related Diarrhea
20-242
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an open-label, non-randomized pilot trial.
Primary purpose: TREATMENT

Brief summary: 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.

FMT uses a liquid preparation of stool collected from a healthy donor with normal (healthy) bacteria; this liquid is infused into the small or large intestine of a recipient during a colonoscopy procedure. The study researchers think that the healthy bacteria in the transplanted stool will grow and replace the unhealthy bacteria and return the intestines and colon of the recipient to a healthy state.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of fecal microbiota transplantation (FMT)-related adverse events
timeFrame: for 7 days after each FMT
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: David Faleck, MD
role: PRINCIPAL_INVESTIGATOR
References: