Whey Protein Milk-Derived Exosomes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorExosomm Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A confirmed clinical diagnosis of UC of any duration
Age 18-65 years
Signed informed consent
Presence of endoscopic evidence of colonic inflammation
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Whey Protein Milk-Derived Exosomes
Dietary supplementWPMDE2 (Whey Protein Milk-Derived Exosomes 2) is an advanced nutritional supplement developed from natural milk components.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Adult patients with ulcerative colitis (UC) of varying disease severity, ranging from mild to severeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Clinical Benefit #1
\- Change in disease activity as measured by clinical activity index from baseline to end of treatment
Time frame
12 months2
Clinical Benefits #2
\- Comparison of clinical benefits between the two dosage groups measured by clinical activity index from baseline to end of treatment
Time frame
12 months3
Safety and Tolerability of WPMDE2 #1
\- Incidence and severity of adverse events.
Time frame
12 monthsSecondary outcomes
1
Change in inflammatory biomarkers #1
\- Fecal calprotectin levels
Time frame
12 months2
Change in inflammatory biomarkers #2
\- Change in endoscopic subscore of the clinical activity index from baseline to end of treatment
Time frame
12 months3
Improvement in the quality of life
Improvement in the quality of life as measured by IBDQ-32
Time frame
12 months4
Patient-reported outcomes #1
Changes in stool frequency assessed by the IBDQ-32 questionnaire Changes in rectal bleeding Changes in abdominal pain/discomfort
Time frame
12 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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