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

Study acronym: PROF
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: May 2026 to May 31, 2027
    • Study completion date: Jun 2026 to Jul 31, 2027
    • Site details revised at 8 of 8 sites
    v11
  2. Site contacts updated at 8 of 8 sitesv10
  3. Site details revised at 1 of 8 sitesv9
  4. Re-verified, no change to tracked fieldsv8
  5. Primary completion date: Jan 2025 to May 2026v7 Show 4 more changesShow less
    • Study sites: 6 to 8
    • Study completion date: Jun 2025 to Jun 2026
    • Start date: Oct 11, 2023 to Nov 6, 2023
    • Eligibility criteria expanded, about 474 words
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites revised (6)v6
  2. Study sites: 4 to 6v5
  3. Site details revised at 1 of 4 sitesv4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2023 to Oct 11, 2023
    • Site details revised at 4 of 4 sites
    v3
  5. Study sites revised (4)v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05938465
Lead Sponsor Exegi Pharma, LLC
Collaborators: The Emmes Company, LLC
Conditions
(from sponsor)		 Ileal Pouch
Related terms Pouchitis
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov