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

Description

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.

Conditions

Ileal Pouch

Study Overview

Study Details

Study overview

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.

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

Condition
Ileal Pouch
Intervention / Treatment

-

Contacts and Locations

Grand Rapids

Corewell Health, Grand Rapids, Michigan, United States, 49503

Rochester

Mayo Clinic Department of Gastroenterology, Rochester, Minnesota, United States, 55905

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

New York

NYU Langone Health, New York, New York, United States, 10016

Chapel Hill

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States, 27599

Hershey

Penn State Health (Milton S. Hershey Medical Center), Hershey, Pennsylvania, United States, 17033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to 65 Years

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Exegi Pharma, LLC,

    Melody Khorrami, PharmD, RPh, STUDY_DIRECTOR, Exegi Pharma, LLC

    Study Record Dates

    2025-06