IBD
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTWhey Protein Milk-Derived EVs
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).
Sponsors
Exosomm Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Tolerability: Identification of dose ranges that do not cause discomfort or adverse symptoms over the study period.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy participants who have not undergone any major surgeries or hospitalization 6 months prior to entering the study * All genders * Participants aged 18-60 * Participants with no underlying known health or mental conditions * Participants who are not participating in another clinical study simultaneously or taking any other nutritional supplements or chronic drugs. * Participants must pre-sign the informed consent form.
Exclusion criteria
* Participants who violate one or more of the inclusion criteria * participants with chronic diseases, particularly those that are related to the GI tract * Participants with cow milk allergy/ intolerance or history of such. * Participants suffering from constipation or diarrhea * Participants who use drugs or drink alcohol on a regular basis (more than one glass per week) * Pregnant or breastfeeding women * Participants with a BMI over 30
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of adverse symptoms over the study period. | up to 30 days | Tolerability: Identification of dose ranges that do not cause discomfort or adverse symptoms over the study period. |
Countries
Israel
Outcome results
None listed