Can friendly bacteria tame a troubled pouch? new trial aims to cut bathroom trips

NCT ID NCT05938465

First seen May 29, 2026 · Last updated Jun 22, 2026 · Updated 4 times

Summary

This study tests a live biotherapeutic called EXE-346, made from 8 strains of lactic acid bacteria, to see if it can safely reduce high bowel movement frequency in people with an ileal pouch-anal anastomosis (IPAA). About 50 participants will receive either EXE-346 or a placebo. The goal is to improve quality of life by cutting down on daily bathroom visits.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

    Contact Email: •••••@•••••

  • Corewell Health

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

    Contact

    Contact Email: •••••@•••••

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Mayo Clinic - Florida (Inflammatory Bowel Disease Center)

    RECRUITING

    Jacksonville, Florida, 32224, United States

    Contact

    Contact Email: •••••@•••••

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Mayo Clinic Department of Gastroenterology

    RECRUITING

    Rochester, Minnesota, 55905, United States

    Contact Email: •••••@•••••

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact Email: •••••@•••••

    Contact

  • Penn State Health (Milton S. Hershey Medical Center)

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact Email: •••••@•••••

    Contact

What this could mean

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

Active substance

EXE-346 (a blend of 8 strains of lactic acid bacteria)

What this could lead to

If it works, this could offer a new way to reduce bowel movement frequency and improve quality of life for people with an ileal pouch.

What could go wrong

This is an early phase 1b/2 trial with only 50 participants, so results may not apply to everyone. The treatment may not work or could cause side effects.

Conditions

The condition(s) this trial relates to.

pouchitis

As listed by the trial registrant

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