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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

November 6, 2023

Primary Completion Date

May 31, 2026

Study Completion Date

June 30, 2026

Conditions
Ileal Pouch
Interventions
BIOLOGICAL

EXE-346

EXE-346 contains a proprietary, fixed-dose, lyophilized blend of 8 strains of gram positive, lactic acid bacteria. EXE-346 excipients are maltose and silicon dioxide.

OTHER

Placebo

Placebo contains excipients maltose and silicon dioxide.

Trial Locations (8)

10016

RECRUITING

NYU Langone Health, New York

17033

RECRUITING

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

27599

RECRUITING

University of North Carolina at Chapel Hill, Chapel Hill

32224

NOT_YET_RECRUITING

Mayo Clinic - Florida (Inflammatory Bowel Disease Center), Jacksonville

49503

NOT_YET_RECRUITING

Corewell Health, Grand Rapids

55905

RECRUITING

Mayo Clinic Department of Gastroenterology, Rochester

63110

RECRUITING

Washington University School of Medicine, St Louis

90048

RECRUITING

Cedars-Sinai Medical Center, Los Angeles

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

The Emmes Company, LLC

INDUSTRY

lead

Exegi Pharma, LLC

INDUSTRY

NCT05938465 - Study of EXE-346 Live Biotherapeutic to Reduce High Bowel Movement Frequency in Subjects With an IPAA (PROF) | Biotech Hunter | Biotech Hunter