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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Exegi Pharma, LLC
Study ID
NCT05938465
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Ileal Pouch

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EXE-346 — BIOLOGICAL
    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.
  • Placebo — OTHER
    Placebo contains excipients maltose and silicon dioxide.

Study Details

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 Dates

Start date
Nov 6, 2023
Status verified
May 2026
Primary completion
May 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1b Open Label
    EXE-346 live biotherapeutic product, 1500x10\^9 colony forming units (CFU) twice daily (BID), 4 weeks
  • Experimental: Phase 2: Active Arm
    EXE-346 live biotherapeutic product, 1500x10\^9 CFU BID, 8 weeks
  • Placebo Comparator: Phase 2: Placebo Arm
    Powder containing same inactive ingredients as EXE-346 but none of the active ingredients, BID, 8 weeks
  • Experimental: Phase 2 Open Label Extension (optional)
    EXE-346 live biotherapeutic product, 1500x10\^9 CFU BID, 8 weeks

Primary Outcome Measure

Phase 1b: Incidence, Severity, Relatedness, and Frequency of Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) [ Time Frame: 4 weeks ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Gayane Ovsepyan
[email protected]
310-289-9224
Zeyda Cuevas
[email protected]
Phillip Fleshner, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic - Florida (Inflammatory Bowel Disease Center)JacksonvilleFlorida32224
Nic Dybel
[email protected]
904-953-4324
Mallory Gregory
[email protected]
Francis Farraye, MD (PRINCIPAL_INVESTIGATOR)
Corewell HealthGrand RapidsMichigan49503
Rachel Gross
[email protected]
616-391-3825
Jennifer Nguyen
[email protected]
Andrew Shreiner, MD, PhD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Department of GastroenterologyRochesterMinnesota55905
Patricia Kammer
[email protected]
507-538-1827
Christian Cox
[email protected]
Darrell S Pardi, MD, MSc (PRINCIPAL_INVESTIGATOR)
Washington University School of MedicineSt LouisMissouri63110
Katherine Huang
[email protected]
314-273-0301
Monique Lavalas
[email protected]
Parakkal Deepak, MBBS, MS (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
Alexa Miller
[email protected]
646-501-8818
Raashi Jain
[email protected]
Shannon Chang, MD (PRINCIPAL_INVESTIGATOR)
University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Mikki Sandridge
[email protected]
919-843-3873
Hannah Gann
[email protected]
919-843-6961
Hans H Herfarth, MD, PhD (PRINCIPAL_INVESTIGATOR)
Penn State Health (Milton S. Hershey Medical Center)HersheyPennsylvania17033
Karen Bright
[email protected]
717-531-0003
Ronaldo Paolo Panganiban, MD (PRINCIPAL_INVESTIGATOR)

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