NCT07651332Not yet recruitingPhase 2
A Study of Probiotics in Patients With Acute Ischemic Stroke
Placebo-Controlled, Double-Blind, Phase 2 Trial of Probiotic Supplementation in Acute Ischemic Stroke
Source: ClinicalTrials.gov · Last updated 17 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 11 Jun 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Capital Medical University
- Diseases
- Stroke
- NCT number
- NCT07651332
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 220
- From 1 Sept 2026 to the primary completion date, 30 Jun 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
Other
- 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;
Who the study is looking for
- 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;
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.