IBDNCT06742203
WPMDE1 - Whey Protein Milk-Derived Exosomes Among Healthy Subjects
A study testing Whey Protein Milk-Derived EVs in people with IBD, run by Exosomm Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- IBD
- What is being tested?
- Whey Protein Milk-Derived EVs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2023to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: WPMDE1 - Whey Protein Milk-Derived Exosomes Among Healthy Subjects- a Phase 1, Single-center, Open-label Study
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).
Read the 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.
- Conditions
- IBD
- Being tested
- Whey Protein Milk-Derived EVs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey Protein Milk-Derived EVsDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Whey Protein Milk-Derived EVs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start1 Oct 2023
- Primary completion1 Mar 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Tolerability: Identification of dose ranges that do not cause discomfort or adverse symptoms over the study period.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exosomm Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742203
- Sponsor's protocol ID
- WPMDE1
- Status last verified
- Dec 2024
- First submitted
- 15 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WPMDE1 - Whey Protein Milk-Derived Exosomes Among Healthy Subjects- a Phase 1, Single-center, Open-label Study
- ClinicalTrials.gov ID
- NCT06742203
- Acronym / sponsor ID
- WPMDE1
- Conditions
- IBD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Exosomm Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Tolerability: Identification of dose ranges that do not cause discomfort or adverse symptoms over the study period.
| Arm | Type | Receives |
|---|---|---|
| Exosomm treatment | Experimental | Dietary Supplement: Whey Protein Milk-Derived EVsExperimental Group: WPMDE1 - Whey Protein Milk-Derived Exosomes Administered as a powder dissolved in water and taken orally twice daily in pre-measured sachets. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey Protein Milk-Derived EVsWPMDE1 - 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). | Dietary supplement | Exosomm treatment |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey Protein Milk-Derived EVs in people with IBD, run by Exosomm Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability of adverse symptoms over the study period. (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.