A Study of Probiotics in Patients With Acute Ischemic Stroke
ConditionIschemic Stroke
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorCapital Medical University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
probiotic supplement OMNi-BiOTiC® SR-9
Dietary supplementEach sachet contains approximately 7.5 × 10\^9 live bacteria. Administered orally twice daily.
Matching Placebo
Other interventionIdentical in appearance, packaging, and administration method to the probiotic preparation, with no active ingredients.
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Probiotic groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Beta diversity of gut microbiota at Day 90±3 (treatment vs. placebo)
Beta diversity assessed using stool samples at Day 90±3. PERMANOVA will be used to evaluate differences in microbial community composition between treatment arms. This endpoint captures global, community-level alterations of gut microbiota reflecting probiotic-induced ecosystem restructuring in the post-stroke setting, rather than changes in individual taxa alone.
Time frame
Day 90 ± 3 daysSecondary outcomes
1
Modified Rankin Scale (mRS) score at Day 90±3
The mRS evaluates degree of disability or dependence in daily activities post-stroke. Scores range from 0 to 6, with higher scores indicating worse outcome.
Time frame
Day 90 ± 3 days2
Change in modified Rankin Scale (mRS) score from baseline to Day 90±3
Calculated as change of mRS at Day 90±3 compared with mRS at baseline. The mRS is a 7-point scale from 0 to 6, with higher scores indicating worse outcome.
Time frame
Baseline to Day 90 ± 3 days3
Changes in gut microbiota diversity and relative abundance of Prevotella copri at Day 90±3
Temporal beta diversity indices (TBI) will assess changes in beta diversity from baseline to Day 90±3. Changes in alpha diversity will be calculated using Abundance-based Coverage Estimator (ACE), expressed as ACE at Day 90±3 minus ACE at baseline. Relative abundance of Prevotella copri in stool samples at Day 90±3 will be compared between verum and placebo groups.
Time frame
Baseline to Day 90 ± 3 days4
Serum concentrations of short-chain fatty acids (SCFAs) at Day 90±3
Measured SCFAs include acetate, butyrate, and propionate. Evaluates metabolic changes associated with gut microbiota modulation.
Time frame
Baseline and Day 90 ± 3 daysLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: