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COMPLETED
NCT06755021
NA

Whey Protein Milk-Derived Exosomes

Sponsor: Exosomm Ltd.

View on ClinicalTrials.gov

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

DIETARY_SUPPLEMENT

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