Fecal Microbiota Transplantation (FMT)Phase 1NCT04883762
Stool Transplant to Control Treatment-related Diarrhea
A Phase 1 study testing Fecal Microbiota Transplantation (FMT) in people with Fecal Microbiota Transplantation (FMT), run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Microbiota Transplantation (FMT)
- What is being tested?
- Fecal Microbiota Transplantation (FMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2021to May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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.
- Conditions
- Fecal Microbiota Transplantation (FMT)
- Being tested
- Fecal Microbiota Transplantation (FMT)
- Keywords
- Immune Checkpoint Inhibitor (ICI)-Related Diarrhea, 20-242
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota Transplantation (FMT)Biological
Undergo FMT via colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Fecal Microbiota Transplantation (FMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of fecal microbiota transplantation (FMT)-related adverse events
will be grading according to CTCAE 5.0.1
Measured: for 7 days after each FMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start10 May 2021
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal Microbiota Transplantation (FMT)Studies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open-label, non-randomized pilot trial.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Faleck, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883762
- Sponsor's protocol ID
- 20-242
- Status last verified
- Jun 2026
- First submitted
- 10 May 2021
- Last updated
- 3 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation (FMT) for Immune Checkpoint Inhibitor (ICI)-Related Diarrhea: A Pilot Study
- ClinicalTrials.gov ID
- NCT04883762
- Acronym / sponsor ID
- 20-242
- Conditions
- Fecal Microbiota Transplantation (FMT)
- Keywords
- Immune Checkpoint Inhibitor (ICI)-Related Diarrhea, 20-242
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label, non-randomized pilot trial.
| Arm | Type | Receives |
|---|---|---|
| Fecal Microbiota Transplantation (FMT) | Experimental | Biological: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (13 listed)
- 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:
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbiota Transplantation (FMT)Undergo FMT via colonoscopy. | Biological | Fecal Microbiota Transplantation (FMT) |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Faleck, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fecal Microbiota Transplantation (FMT) in people with Fecal Microbiota Transplantation (FMT), run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of fecal microbiota transplantation (FMT)-related adverse events (time frame: for 7 days after each FMT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.