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NCT07651332
A Study of Probiotics in Patients With Acute Ischemic Stroke
Conditions: Ischemic Stroke
Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 220
Sponsor: Capital Medical University
Summary
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.
Eligibility Criteria
Inclusion Criteria:
1. Age ≥ 60 years;
2. 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;
3. Randomization within 72 hours of symptom onset;
4. Ability to provide written informed consent;
5. Baseline NIHSS \>=4;
6. Pre-stroke mRS \
Source: ClinicalTrials.gov (NCT07651332). StuddyBuddy aggregates publicly available trial information.