MedTrace Logo

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

NCT05938465 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-02-24

No results posted yet for this study

Summary

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

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.

Sponsors & Collaborators

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • Exegi Pharma, LLC

    lead INDUSTRY

Principal Investigators

  • Julia Collins, MS · Exegi Pharma, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-06
Primary Completion
2026-05-31
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05938465 on ClinicalTrials.gov