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Whey Protein Milk-Derived Exosomes
Sponsor: Exosomm Ltd.
Summary
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.
Official title: Whey Protein Milk-Derived Exosomes Among Ulcerative Colitis Patients
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
31
Start Date
2025-03-26
Completion Date
2026-06-01
Last Updated
2026-10-16
Healthy Volunteers
No
Interventions
Whey Protein Milk-Derived Exosomes
WPMDE2 (Whey Protein Milk-Derived Exosomes 2) is an advanced nutritional supplement developed from natural milk components.
Locations (4)
Soroka Medical Center
Beersheba, Israel
Hadassah Medical Center
Jerusalem, Israel
Lev Talpiot Gastroenterology Clinic, Clalit Health Services
Jerusalem, Israel
Meir Medical Center
Kfar Saba, Israel