Stool Transplant to Control Treatment-related Diarrhea

NCT04883762 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 20-242
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Fecal Microbiota Transplantation (FMT)

Keywords

Immune Checkpoint Inhibitor (ICI)-Related Diarrhea; 20-242

Outcome Measures

Primary Outcomes (1)

• Incidence of fecal microbiota transplantation (FMT)-related adverse events

  will be grading according to CTCAE 5.0.1

  for 7 days after each FMT

Study Arms (1)

Fecal Microbiota Transplantation (FMT)

EXPERIMENTAL

Study subjects will undergo standard bowel preparation and diagnostic colonoscopy with routine biopsies for pathologic assessment. FMT will be performed at the proximal extent of the colon reached, according to the same protocol used in prior randomized studies. FMT will use healthy donor stool provided by OpenBiome, a nonprofit 501(c)(3) organization that provides clinicians and hospitals with screened, filtered and frozen stool to be used for FMT. Routine clinical and research biopsies will be collected during the FMT colonoscopy procedure.

Biological: Fecal Microbiota Transplantation (FMT)

Interventions

Fecal Microbiota Transplantation (FMT) BIOLOGICAL

Undergo FMT via colonoscopy.

Fecal Microbiota Transplantation (FMT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• David Faleck, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open-label, non-randomized pilot trial.

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 12, 2021
• Study Start: May 10, 2021
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)