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

ClinicalTrials.gov ID: NCT05938465

Public ClinicalTrials.gov record NCT05938465. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Jul 22, 2026, 4:08 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1b/2 Study to Demonstrate the Safety and Efficacy of EXE-346 Live Biotherapeutic to Reduce High Bowel Movement Frequency in Subjects With an Ileal Pouch-Anal Anastomosis (PROF). The "PROF" Study.

Study identification

NCT ID: NCT05938465
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Exegi Pharma, LLC; Industry
Enrollment: 50 participants

Conditions and interventions

Conditions

Ileal Pouch

Interventions

EXE-346 Biological
Placebo Other

Biological · Other

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 5, 2023
Primary completion: May 30, 2027
Completion: Jul 30, 2027
Last update posted: May 27, 2026

2023 – 2027

United States locations

U.S. sites: 8
U.S. states: 8
U.S. cities: 8

Facility	City	State	ZIP	Site status
Cedars-Sinai Medical Center	Los Angeles	California	90048	Recruiting
Mayo Clinic - Florida (Inflammatory Bowel Disease Center)	Jacksonville	Florida	32224	Recruiting
Corewell Health	Grand Rapids	Michigan	49503	Recruiting
Mayo Clinic Department of Gastroenterology	Rochester	Minnesota	55905	Recruiting
Washington University School of Medicine	St Louis	Missouri	63110	Recruiting
NYU Langone Health	New York	New York	10016	Recruiting
University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	27599	Recruiting
Penn State Health (Milton S. Hershey Medical Center)	Hershey	Pennsylvania	17033	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05938465, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 27, 2026 · Synced Jul 22, 2026

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The complete protocol, eligibility criteria, and contact information for NCT05938465 live on ClinicalTrials.gov.

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