NCT06755021Completed
Whey Protein Milk-Derived Exosomes
Whey Protein Milk-Derived Exosomes Among Ulcerative Colitis Patients
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 11 Dec 2024
- Start date
- 26 Mar 2025
- Primary completion date
- 20 Apr 2026
- Lead sponsor
- Exosomm Ltd.
- Diseases
- Ulcerative colitis
- NCT number
- NCT06755021
What you commit to
- Study type: Interventional
- Participants enrolled: 31
- From 26 Mar 2025 to the primary completion date, 20 Apr 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participating in another investigational drug study within 30 days of study enrollment
Other illness
- Milk allergy
- Severe co-morbid medical illness such as uncontrolled diabetes, unstable cardiovascular or pulmonary disease, or malignancy
- Evidence of colonic perforation
- Massive hemorrhage from the colon requiring emergent surgery
Lab values
- Specific exclusions: HIV , CMV , Hepatitis B or C, Abnormal AST or ALT at screening defined as \> 3x upper limit of normal
Other
- Pregnancy or breastfeeding
Who the study is looking for
- A confirmed clinical diagnosis of UC of any duration
- Age 18-65 years
- Signed informed consent
- Presence of endoscopic evidence of colonic inflammation
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Soroka Medical Center Coordinator of this site? Confirm its status | Beersheba | Israel | Unknown status |
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Lev Talpiot Gastroenterology Clinic, Clalit Health Services Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Meir Medical Center Coordinator of this site? Confirm its status | Kfar Saba | Israel | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.