Whey Protein Milk-Derived Exosomes Among Ulcerative Colitis Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Primary Endpoint
- Clinical Benefit #1
Study Overview
Brief 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.
Detailed Description
This is a Phase 1B open-label, uncontrolled, multicenter trial designed to evaluate the safety, tolerability, and potential efficacy of WPMDE2 (Whey Protein Milk-Derived Exosomes) in adult patients with varying severities of ulcerative colitis (UC). The study builds upon promising preclinical research and a preceding Phase 1 safety study in healthy volunteers, which demonstrated that WPMDE2 has a favorable safety profile and potential anti-inflammatory benefits. By targeting patients with mild to severe UC, the trial seeks to explore WPMDE2's therapeutic role as an add-on to existing treatment regimens.
Study Objectives
Primary Objectives:
Evaluate the safety and tolerability of WPMDE2 when administered orally at two different dosages.
Assess the clinical benefits of WPMDE2 by measuring changes in disease severity.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
open label study
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •A confirmed clinical diagnosis of UC of any duration
- •Age 18-65 years
- •Signed informed consent
- •Presence of endoscopic evidence of colonic inflammation
Exclusion Criteria
- •Pregnancy or breastfeeding
- •Milk allergy
- •Severe co-morbid medical illness such as uncontrolled diabetes, unstable cardiovascular or pulmonary disease, or malignancy
- •Specific exclusions: HIV , CMV , Hepatitis B or C, Abnormal AST or ALT at screening defined as > 3x upper limit of normal
- •Participating in another investigational drug study within 30 days of study enrollment
- •Evidence of colonic perforation
- •Massive hemorrhage from the colon requiring emergent surgery
Outcomes
Primary Outcomes
Clinical Benefit #1
Time Frame: 12 months
- Change in disease activity as measured by clinical activity index from baseline to end of treatment
Clinical Benefits #2
Time Frame: 12 months
- Comparison of clinical benefits between the two dosage groups measured by clinical activity index from baseline to end of treatment
Safety and Tolerability of WPMDE2 #1
Time Frame: 12 months
- Incidence and severity of adverse events.
Secondary Outcomes
- Change in inflammatory biomarkers #1(12 months)
- Change in inflammatory biomarkers #2(12 months)
- Improvement in the quality of life(12 months)
- Patient-reported outcomes #1(12 months)
- Patient-reported outcomes #2(12 months)
- Dose-response relationship:(12 months)