Study of EXE-346 Live Biotherapeutic to Reduce High Bowel Movement Frequency in Subjects With an IPAA (PROF)
Recruiting now · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Ileal Pouch
In brief
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.
Key facts
- Study ID
- NCT05938465
- Run by
- Exegi Pharma, LLC
- People needed
- 50
- Starts
- 2023-11-06
- Expected to finish
- 2027-07-31
- Last updated by the study team
- 2026-05-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
- Mayo Clinic - Florida (Inflammatory Bowel Disease Center) — Jacksonville, Florida, United States (enrolling)
- Corewell Health — Grand Rapids, Michigan, United States (enrolling)
- Mayo Clinic Department of Gastroenterology — Rochester, Minnesota, United States (enrolling)
- Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
- NYU Langone Health — New York, New York, United States (enrolling)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
- Penn State Health (Milton S. Hershey Medical Center) — Hershey, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.