A Study of Probiotics in Patients With Acute Ischemic Stroke
Starting soon · Phase 2 · Has a placebo group
Conditions studied: Ischemic Stroke
In brief
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.
Key facts
- Study ID
- NCT07651332
- Run by
- Capital Medical University
- People needed
- 220
- Starts
- 2026-09-01
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-06-17
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 60 years;
- 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;
- Randomization within 72 hours of symptom onset;
- Ability to provide written informed consent;
- Baseline NIHSS >=4;
- Pre-stroke mRS <=2;
You may not qualify if…
- Suspected lack of compliance;
- Presence of moderate to severe dysphagia;
- Current participation in other interventional trials or recent participation (within the last 30 days) in an interventional trial;
- Known allergy or hypersensitivity to trial compounds components or placebo;
- 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;
- Malignant diseases including active malignancies with a life expectancy of less than 3 months;
- Major gastro-intestinal (GI) surgery, chronic inflammatory diseases of the gut and significant GI-neoplasms;
Full record on ClinicalTrials.gov
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