Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT06742203
Status:
COMPLETED
Last Update Posted:
2024-12-31
First Post:
2024-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
WPMDE1 - Whey Protein Milk-Derived Exosomes Among Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Tolerability: Identification of dose ranges that do not cause discomfort or adverse symptoms over the study period.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-30', 'studyFirstSubmitDate': '2024-12-15', 'studyFirstSubmitQcDate': '2024-12-15', 'lastUpdatePostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tolerability of adverse symptoms over the study period.', 'timeFrame': 'up to 30 days', 'description': 'Tolerability: Identification of dose ranges that do not cause discomfort or adverse symptoms over the study period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['IBD']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': "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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy participants who have not undergone any major surgeries or hospitalization 6 months prior to entering the study\n* All genders\n* Participants aged 18-60\n* Participants with no underlying known health or mental conditions\n* Participants who are not participating in another clinical study simultaneously or taking any other nutritional supplements or chronic drugs.\n* Participants must pre-sign the informed consent form.\n\nExclusion Criteria:\n\n* Participants who violate one or more of the inclusion criteria\n* participants with chronic diseases, particularly those that are related to the GI tract\n* Participants with cow milk allergy/ intolerance or history of such.\n* Participants suffering from constipation or diarrhea\n* Participants who use drugs or drink alcohol on a regular basis (more than one glass per week)\n* Pregnant or breastfeeding women\n* Participants with a BMI over 30'}, 'identificationModule': {'nctId': 'NCT06742203', 'briefTitle': 'WPMDE1 - Whey Protein Milk-Derived Exosomes Among Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Exosomm Ltd.'}, 'officialTitle': 'WPMDE1 - Whey Protein Milk-Derived Exosomes Among Healthy Subjects- a Phase 1, Single-center, Open-label Study', 'orgStudyIdInfo': {'id': 'WPMDE1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exosomm treatment', 'description': 'Experimental Group: WPMDE1 - Whey Protein Milk-Derived Exosomes\n\nAdministered as a powder dissolved in water and taken orally twice daily in pre-measured sachets.', 'interventionNames': ['Dietary Supplement: Whey Protein Milk-Derived EVs']}], 'interventions': [{'name': 'Whey Protein Milk-Derived EVs', 'type': 'DIETARY_SUPPLEMENT', 'description': '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).', 'armGroupLabels': ['Exosomm treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Exosomm Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}