[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642146":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":26,"responsibleParty":42,"collaborators":26,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":26,"enrollmentInfo":55,"targetDuration":26,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":66,"whyStopped":26,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":26},{"fullName":5,"class":6},"Capital Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Probiotic group","EXPERIMENTAL","Subjects receive the probiotic supplement OMNi-BiOTiC® SR-9 orally twice daily, one sachet each time, with each sachet containing approximately 7.5 × 10\\^9 live bacteria.",[13],"Dietary Supplement: probiotic supplement OMNi-BiOTiC® SR-9",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo group","PLACEBO_COMPARATOR","Subjects receive placebo orally twice daily, one sachet each time, consisting of an equal volume of starch, with appearance, packaging, and administration method identical to the probiotic preparation.",[19],"Other: Matching Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","probiotic supplement OMNi-BiOTiC® SR-9","Each sachet contains approximately 7.5 × 10\\^9 live bacteria. Administered orally twice daily.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Matching Placebo","Identical in appearance, packaging, and administration method to the probiotic preparation, with no active ingredients.",[15],[32],{"name":33,"affiliation":34,"role":35},"Xunming Ji, PhD, MD","Xuanwu Hospital, Beijing","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Lan Liu, PhD","CONTACT","8683911991","liulan1815@outlook.com",{"type":35,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Ji Xunming,MD,PhD","Principal Investigator","100642146","phase-2-a-study-of-probiotics-in-patients-with-acute-ischemic-stroke-100642146",false,"NCT07651332","A Study of Probiotics in Patients With Acute Ischemic Stroke","Placebo-Controlled, Double-Blind, Phase 2 Trial of Probiotic Supplementation in Acute Ischemic Stroke","PRO-STROKE","Inclusion Criteria:\n\n1. Age ≥ 60 years;\n2. Diagnosis of ischemic stroke; (1)Ischemic stroke is defined as clinically manifest acute neurological deficits linked to an acute cerebral infarct in the anterior circulation; (2)Central retinal artery occlusion or likely central retinal artery occlusion are not considered ischemic strokes in the context of this trial;\n3. Randomization within 72 hours of symptom onset;\n4. Ability to provide written informed consent;\n5. Baseline NIHSS \\>=4;\n6. Pre-stroke mRS \\\u003C=2;\n\nExclusion Criteria:\n\n1. Suspected lack of compliance;\n2. Presence of moderate to severe dysphagia;\n3. Current participation in other interventional trials or recent participation (within the last 30 days) in an interventional trial;\n4. Known allergy or hypersensitivity to trial compounds components or placebo;\n5. No known history before randomization of imminently life-shortening medical conditions or any other reason, including any physical, psychological, or psychiatric condition that in the investigator's opinion would compromise the safety or interfere with the subject's participation in this study, or would make the subject an unsuitable candidate to receive study drug, or would put the subject at risk by participating in the study;\n6. Malignant diseases including active malignancies with a life expectancy of less than 3 months;\n7. Major gastro-intestinal (GI) surgery, chronic inflammatory diseases of the gut and significant GI-neoplasms;","ALL","60 Years",{"count":56,"type":57},220,"ESTIMATED","INTERVENTIONAL",[60],"PHASE2","The primary objective of this study is to evaluate the effect of daily oral administration of the probiotic supplement OMNi-BiOTiC® SR-9 for 90 days, compared to placebo, on gut microbiome beta diversity in patients aged 60 years or older with acute ischemic stroke.",[63],"Ischemic Stroke",[65],"ischemic stroke","NOT_YET_RECRUITING","2026-06-16",{"date":69,"type":70},"2026-06-17","ACTUAL",{"date":72,"type":57},"2026-09-01",{"date":74,"type":57},"2027-12-31",{"name":5,"class":6}]