Whey Protein Milk-Derived Exosomes

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Completed without a posted recruiting period Show 8 more changesShow less
    • Trial sites expanded: 0 → 4 locations
    • Final enrollment: 31 participants (planned 100)
    • Primary completion date changed from estimate of Feb 1, 2026 to Apr 20, 2026
    • Study completion date changed from estimate of Apr 1, 2026 to Jun 1, 2026
    • Start date changed from estimate of Feb 24, 2025 to Mar 26, 2025
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 3 of 6 entries
    • Study description revised
  2. Start date: Feb 1, 2025 to Feb 24, 2025
    • Secondary endpoints: details revised at 2 of 6 entries
    • Study description shortened, about 22 words
    v2
  3. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This Phase 1B open-label, uncontrolled multicenter trial evaluates the safety, tolerability, and potential efficacy of WPMDE2, a whey protein milk-derived exosome supplement, in adult patients with mild to severe ulcerative colitis (UC). The study aims to explore clinical improvements in disease activity, quality of life, and inflammatory markers over an 8-week intervention period with a 2-week follow-up. WPMDE2 is administered orally in two dosage groups, with 100 participants stratified by disease severity. Key endpoints include changes in disease severity, fecal calprotectin levels, and patient-reported outcomes. Conducted under ethical guidelines, the study seeks to establish WPMDE2 as a safe, naturally derived adjunct therapy for UC patients.
Trial Details
NCT Number NCT06755021
Lead Sponsor Exosomm Ltd.
Conditions
(from sponsor)		 Ulcerative Colitis, Inflammatory Bowel Disease
Related terms Colitis, Ulcerative, Inflammatory Bowel Diseases
Enrollment 31 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov