[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574110":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":20,"responsibleParty":36,"collaborators":20,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":17,"officialTitle":42,"acronym":20,"eligibilityCriteria":43,"healthyVolunteers":40,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":20,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":20,"overallStatus":57,"whyStopped":20,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":20},{"fullName":5,"class":6},"Exosomm Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Adult patients with ulcerative colitis (UC) of varying disease severity, ranging from mild to severe","EXPERIMENTAL","Participants will be sequentially allocated to the two dosage groups in a 1:1 ratio: dosage X and dosage 2X and stratified by disease severity",[13],"Dietary Supplement: Whey Protein Milk-Derived Exosomes",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIETARY_SUPPLEMENT","Whey Protein Milk-Derived Exosomes","WPMDE2 (Whey Protein Milk-Derived Exosomes 2) is an advanced nutritional supplement developed from natural milk components.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Lior Kats, MD","Hadassah Medical Organization","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Netta Granot","CONTACT","972-546765638","netta@exosomm.com",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},"Hila Kfir","972-523313350","hilak@exosomm.com",{"type":37,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100574110","whey-protein-milk-derived-exosomes-100574110",false,"NCT06755021","Whey Protein Milk-Derived Exosomes Among Ulcerative Colitis Patients","Inclusion Criteria:\n\n* A confirmed clinical diagnosis of UC of any duration\n* Age 18-65 years\n* Signed informed consent\n* Presence of endoscopic evidence of colonic inflammation\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Milk allergy\n* Severe co-morbid medical illness such as uncontrolled diabetes, unstable cardiovascular or pulmonary disease, or malignancy\n* Specific exclusions: HIV , CMV , Hepatitis B or C, Abnormal AST or ALT at screening defined as \\> 3x upper limit of normal\n* Participating in another investigational drug study within 30 days of study enrollment\n* Evidence of colonic perforation\n* Massive hemorrhage from the colon requiring emergent surgery","ALL","18 Years","65 Years",{"count":48,"type":49},100,"ESTIMATED","INTERVENTIONAL",[52],"NA","This Phase 1B open-label, uncontrolled multicenter trial evaluates the safety, tolerability, and potential efficacy of WPMDE2, a whey protein milk-derived exosome supplement, in adult patients with mild to severe ulcerative colitis (UC). The study aims to explore clinical improvements in disease activity, quality of life, and inflammatory markers over an 8-week intervention period with a 2-week follow-up. WPMDE2 is administered orally in two dosage groups, with 100 participants stratified by disease severity. Key endpoints include changes in disease severity, fecal calprotectin levels, and patient-reported outcomes. Conducted under ethical guidelines, the study seeks to establish WPMDE2 as a safe, naturally derived adjunct therapy for UC patients.",[55,56],"Ulcerative Colitis","Inflammatory Bowel Disease","NOT_YET_RECRUITING","2025-02-23",{"date":60,"type":61},"2025-02-25","ACTUAL",{"date":63,"type":49},"2025-02-24",{"date":65,"type":49},"2026-04-01",{"name":5,"class":6}]