- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04883762
Stool Transplant to Control Treatment-related Diarrhea
Fecal Microbiota Transplantation (FMT) for Immune Checkpoint Inhibitor (ICI)-Related Diarrhea: A Pilot Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: David Faleck, MD
- Phone Number: 212-639-3904
- Email: faleckd@mskcc.org
Study Contact Backup
- Name: Robin Mendelsohn, MD
- Phone Number: 212-639-8152
Study Locations
-
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fecal Microbiota Transplantation (FMT)
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.
|
Undergo FMT via colonoscopy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of fecal microbiota transplantation (FMT)-related adverse events
Time Frame: for 7 days after each FMT
|
will be grading according to CTCAE 5.0.1
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for 7 days after each FMT
|
Collaborators and Investigators
Investigators
- Principal Investigator: David Faleck, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-242
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fecal Microbiota Transplantation (FMT)
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Assistance Publique - Hôpitaux de ParisUniversity of Paris 5 - Rene Descartes; Institut National de Recherche pour...WithdrawnFecal Microbiota Transplantation
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Keimyung University Dongsan Medical CenterRecruitingFecal Microbiota TransplantationKorea, Republic of
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University Hospital of North NorwayCompletedFecal Microbiota TransplantationNorway
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MaaT PharmaTerminatedIntensive Care Units | Fecal Microbiota TransplantationFrance
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Shanghai 10th People's HospitalCompletedSmall Intestinal Bacterial Overgrowth | Fecal Microbiota TransplantationChina
-
Guangzhou First People's HospitalRecruitingFecal Microbiota TransplantationChina
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Academisch Medisch Centrum - Universiteit van Amsterdam...RecruitingProbiotics | Non-Alcoholic Fatty Liver Disease | Microbiome | Gut Microbiome | Fecal Microbiota Transplantation | Intestinal Microbiome | FMT | Non Alcoholic Steatohepatitis | PrebioticsNetherlands
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Michael ScharlRecruitingCancer | Immunotherapy | Immune Checkpoint Inhibitors | Fecal Microbiota TransplantationSwitzerland
-
MaaT PharmaCompletedFecal Microbiota TransplantationFrance, Italy, Poland
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Helsinki University Central HospitalUniversity of HelsinkiActive, not recruitingFecal Microbiota Transplantation | Cesarean Section, Affecting Fetus or Newborn | Intestinal MicrobiomeFinland
Clinical Trials on Fecal Microbiota Transplantation (FMT)
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Memorial Sloan Kettering Cancer CenterActive, not recruitingAllogeneic Hematopoietic Stem CellUnited States
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Children's Mercy Hospital Kansas CityUniversity of Pittsburgh; Stanford UniversityCompletedUlcerative Colitis (UC) | Inflammatory Bowel Diseases (IBD) | Crohn's Disease (CD)United States
-
Massachusetts General HospitalCompleted
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The Second Hospital of Nanjing Medical UniversityFuzhou General HospitalUnknown
-
University Hospital of North NorwayOslo University Hospital; Haukeland University Hospital; Sorlandet Hospital HF; Alesund HospitalActive, not recruitingIrritable Bowel SyndromeNorway
-
Susy HotaSinai Health System, Ontario, Canada; University of Toronto, Ontario, Canada; The Toronto Invasive Bacterial Diseases Network, Ontario, Canada and other collaboratorsSuspended
-
Brigham and Women's HospitalIcahn School of Medicine at Mount Sinai; The Miriam Hospital; Indiana UniversityCompletedInflammatory Bowel Diseases | Clostridium Difficile InfectionUnited States
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Children's Hospital Los AngelesCompleted
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Fondazione Policlinico Universitario Agostino Gemelli...RecruitingIrritable Bowel SyndromeItaly
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LifespanUnknownNonalcoholic Fatty Liver DiseaseUnited States