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This phase 1, single-center, open-label study aims to evaluate the tolerability and usability of WPMDE1, a whey protein milk-derived exosome (EV) nutritional supplement, in healthy adults. The study will assess dose tolerability and determine the appropriate dosage for future studies targeting patients with Irritable Bowel Syndrome (IBS) and Inflammatory Bowel Disease (IBD).
WPMDE1 is a nutritional supplement derived from cow's milk using a novel production process designed to preserve extracellular vesicles (EVs) and their biological functions. This single-arm, unblinded trial will explore the effects of ascending doses of WPMDE1 on tolerability and usability in up to 30 healthy adults aged 18-60. Participants will be divided into five groups to test incremental doses over 7-30 days.
The study includes blood sampling, vital sign measurements, and daily symptom tracking via validated gastrointestinal symptom questionnaires. The outcomes will inform the design of future clinical trials targeting IBS and IBD patients. The trial will be conducted at Hadassah University Hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exosomm treatment | Experimental | Experimental Group: WPMDE1 - Whey Protein Milk-Derived Exosomes Administered as a powder dissolved in water and taken orally twice daily in pre-measured sachets. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey Protein Milk-Derived EVs | Dietary Supplement | WPMDE1 - Whey Protein Milk-Derived EVs, is a white powder obtained by filtration, concentration, and dehydrating whey solution, with the addition of sweeteners and flavorings to balance the taste. The WPMDE1 contains a known concentration of EVs (also known as milk exosomes). |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of adverse symptoms over the study period. | Tolerability: Identification of dose ranges that do not cause discomfort or adverse symptoms over the study period. | up to 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Center | Jerusalem | Israel |
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Tolerability: Identification of dose ranges that do not cause discomfort or adverse symptoms over the study period.
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