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Study identifier: NCT05938465 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Study of EXE-346 Live Biotherapeutic to Reduce High Bowel Movement Frequency in Subjects With an IPAA (PROF)

Condition: Ileal Pouch  ·  Sponsor: Exegi Pharma, LLC

PhasePhase 1/Phase 2
Planned participants50
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

The aim of this study is to assess the safety and preliminary efficacy of treatment with EXE-346, a live biotherapeutic, which may reduce bowel movement frequency in patients with an ileal pouch-anal anastomosis (IPAA) and lead to a higher quality of life.

This description comes directly from the study's public registry record.

Talk to the study team

Emmes Project Management  ·  301-251-1161  ·  PROF_Study@emmes.com

Always discuss trial participation with your own doctor first.

Locations (8)

Cedars-Sinai Medical CenterLos Angeles, California, United StatesRecruiting
Mayo Clinic - Florida (Inflammatory Bowel Disease Center)Jacksonville, Florida, United StatesRecruiting
Corewell HealthGrand Rapids, Michigan, United StatesRecruiting
Mayo Clinic Department of GastroenterologyRochester, Minnesota, United StatesRecruiting
Washington University School of MedicineSt Louis, Missouri, United StatesRecruiting
NYU Langone HealthNew York, New York, United StatesRecruiting
University of North Carolina at Chapel HillChapel Hill, North Carolina, United StatesRecruiting
Penn State Health (Milton S. Hershey Medical Center)Hershey, Pennsylvania, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT05938465