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WPMDE1 - Whey Protein Milk-Derived Exosomes Among Healthy Subjects

NCT ID: NCT06742203

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-04-01

Brief Summary

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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).

Detailed Description

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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.

Conditions

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IBD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exosomm treatment

Experimental Group: WPMDE1 - Whey Protein Milk-Derived Exosomes

Administered as a powder dissolved in water and taken orally twice daily in pre-measured sachets.

Group Type EXPERIMENTAL

Whey Protein Milk-Derived EVs

Intervention Type 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).

Interventions

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Whey 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).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Exosomm Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hadassah Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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WPMDE1

Identifier Type: -

Identifier Source: org_study_id