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Bacteria cocktail aims to tame immunotherapy side effects

NCT ID NCT06801067

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 29, 2026 · Updated 3 times

Summary

This early-stage trial tests whether SER-155, a mix of 16 live bacteria taken by mouth, can safely treat severe diarrhea and colon inflammation caused by cancer immunotherapy. The study will enroll 15 adults who have developed these side effects. The main goal is to check safety, but researchers will also see if the treatment can reduce symptoms without needing immune-suppressing drugs.

What this could mean

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

Active substance
SER-155 (a mixture of 16 live bacteria taken by mouth)
What this could lead to
If it works, this could offer a safer, non-immunosuppressive first treatment for severe diarrhea caused by cancer immunotherapy.
What could go wrong
This is a very early Phase 1 trial with only 15 people, so it is primarily testing safety, not effectiveness. The treatment may not work or could cause side effects like bloodstream infection.

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

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Jan 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: * Age \> 18 years * Receipt of ICI (single-agent or combination) within the 180 days preceding screening. Concurrent treatment with cytotoxic chemotherapy or other tumor-directed agents is permitted. * Grade 2 - 3 diarrhea (i.e., increase of at least 4 bowel movements a day above baseline during the screening window), deemed by the treating provider as likely related to ICI therapy, with or without concomitant symptoms of grade 1 - 2 colitis (e.g. abdominal pain, bloody or mucoid stools) * Able to swallow oral medication * Individuals of childbearing potential willing to use a highly effective method of contraception (failure rate of \<1% per year when used consistently and correctly) for 30 days after the last dose of SER-155. * Willing to provide written informed consent, comply with the protocol, and understand the potential risks and benefits of study enrollment and treatment. Exclusion Criteria: * Active GI infection, including untreated viral, bacterial or fungal cause(s) of diarrhea. * Received immunosuppressive therapies for suspected or confirmed irEC, including systemic corticosteroids (either oral or intravenous) and/or infliximab, vedolizumab or ustekinumab * Grade 3 colitis symptoms, i.e. severe abdominal pain or peritoneal signs * Admitted to the hospital for irEC * Prednisone (or steroid equivalent) dose \> 10 mg a day for a non-GI irAE at time of screening * Pre-existing inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis) or microscopic colitis * Pregnant or lactating women * Any condition that requires ongoing prophylactic or therapeutic antibacterial antibiotics * Severe neutropenia, as defined by an absolute neutrophil count (ANC) \< 500 cells/mm\^3, at time of screening * Treatment with investigational medications used for diarrhea/colitis treatment and microbiome therapeutics within 30 days prior to enrollment * Known allergy or intolerance to oral vancomycin * Unable to comply with the protocol requirements * Any condition that in the opinion of the investigator may increase the risk of study participation and/or may interfere with the interpretation of study results

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)

    RECRUITING

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen (All Protocol Activities)

    RECRUITING

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    RECRUITING

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Monmouth (All Protocol Activities)

    RECRUITING

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (Limited protocol activities)

    RECRUITING

    Rockville Centre, New York, 11553, United States

  • Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)

    RECRUITING

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    RECRUITING

    Harrison, New York, 10604, United States

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