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Poop pills or procedure? fecal transplants tested for immunotherapy side effect

NCT ID NCT04883762

Disease control Sponsor: Memorial Sloan Kettering Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests whether fecal microbiota transplantation (FMT) can safely reduce severe diarrhea caused by immune checkpoint inhibitors (ICIs) in cancer patients. Four adults who have persistent diarrhea despite steroids or other medications will receive a stool preparation from a healthy donor via colonoscopy. The goal is to see if the healthy bacteria can restore gut health and ease symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fecal microbiota transplantation (FMT) from a healthy donor
What this could lead to
If it works, this could offer a new way to manage severe diarrhea caused by cancer immunotherapy, helping patients stay on their cancer treatment.
What could go wrong
This is a very early, small pilot study with only 4 participants. The approach may not work for everyone, and there are risks like infection or worsening symptoms.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

4 people

The number who actually took part.

Started

May 2021

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fecal microbiota transplantation (FMT)

Contacts and locations

Locations

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

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