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
Qualifiers
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
Treatments tested in this trial
- probiotic supplement OMNi-BiOTiC® SR-9
- Matching Placebo
Treatment groups
220 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov