WPMDE1 - Whey Protein Milk-Derived Exosomes Among Healthy Subjects

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).

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Key information

Conditions

IBD

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical Center

Jerusalem, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

Tolerability of adverse symptoms over the study period.

Time frame: up to 30 days

Tolerability: Identification of dose ranges that do not cause discomfort or adverse symptoms over the study period.

Sponsors and collaborators

Lead sponsor

Exosomm Ltd.

Industry

Registry information

Official study title

WPMDE1 - Whey Protein Milk-Derived Exosomes Among Healthy Subjects- a Phase 1, Single-center, Open-label Study

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Dec 19, 2024
Registry last updated: Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed