[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622444":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":46,"collaborators":20,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":20,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":20,"enrollmentInfo":58,"targetDuration":20,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":71,"whyStopped":20,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Massachusetts Eye and Ear Infirmary","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Main Arm - twice daily for 4 months","EXPERIMENTAL","This is the only arm in this study. All participants will receive 4 months of Lactobacillus plantarum supplementation.",[13],"Drug: Lactobacillus plantarum 299v",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Lactobacillus plantarum 299v","Lactiplantibacillus Plantarum 299v Probiotic Supplementation, Twice Daily, for 4 Months",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Demetrios G. Vavvas, MD PhD","CONTACT","6175736874","Demetrios_Vavvas@meei.harvard.edu",[28],{"facility":29,"status":20,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Mass Eye and Ear","Boston","Massachusetts","02114","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-71.05977,42.35843,{"lat":39,"lon":38},[42,44],{"name":23,"role":24,"phone":43,"phoneExt":20,"email":26},"617-573-6874",{"name":23,"role":45,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"type":45,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Demetrios Vavvas","Solman and Libe Friedman Professor of Ophthalmology Director Retina Service Mass. Eye and Ear \u002F Mass General Hospital Co-Director Ocular Regenerative Medical Institute Harvard Medical School","100622444","phase-2-lactiplantibacillus-plantarum-299v-probiotic-supplementation-in-patients-with-diabetic-macular-edema-100622444",false,"NCT07383701","Lactiplantibacillus Plantarum 299v Probiotic Supplementation in Patients With Diabetic Macular Edema","Lactiplantibacillus Plantarum 299v Probiotic Probiotic Supplementation in Patients With Diabetic Macular Edema","Inclusion Criteria:\n\n* Age of at least 18 years, presence of DME at the current clinical visit\n\nExclusion Criteria:\n\n* Patients with contraindication to probiotic supplement (e.g. prior allergy or GI intolerance and any type of immunocompromised diseases).","ALL","18 Years",{"count":59,"type":60},36,"ESTIMATED","INTERVENTIONAL",[63],"PHASE2","This pilot prospective, interventional, longitudinal study, aims to evaluate the potential benefits of the probiotic supplement Lactobacillus plantarum 299v in patients with diabetic macular edema (DME).\n\nThe study seeks to address the following questions:\n\n1. Does central macular thickness on optical coherence tomography decrease after 4 months of supplementation?\n2. Is visual acuity improved at 1, 2, 3, and 4 months following initiation of supplementation?\n3. Is the number of anti-VEGF injections reduced following initiation of supplementation?\n\nOutcomes will be compared to a control group, using historic retrospective data.\n\nParticipants will take Lactobacillus plantarum 299v orally twice daily for four months.",[66],"Diabetic Macular Edema",[68,69,70],"diabetic macular edema","Lactiplantibacillus plantarum 299v","probiotic","NOT_YET_RECRUITING","2026-05-17",{"date":74,"type":75},"2026-05-19","ACTUAL",{"date":77,"type":60},"2026-08-01",{"date":79,"type":60},"2027-09-01",{"name":5,"class":6},1]