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Could a daily probiotic boost stroke recovery?
NCT ID NCT07651332
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether taking a probiotic supplement (OMNi-BiOTiC® SR-9) twice daily for 90 days can improve gut health and recovery in people aged 60 and older who have had an acute ischemic stroke. The study will compare the probiotic to a placebo in 220 participants, looking at changes in gut bacteria and disability levels. The goal is to see if a simple dietary supplement can support better outcomes after a stroke.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- probiotic supplement OMNi-BiOTiC® SR-9
- What this could lead to
- If it works, this could point toward a simple, safe way to support recovery after a stroke by improving gut bacteria balance.
- What could go wrong
- This is an early phase 2 trial with only 220 participants, so results may not apply to everyone. The main goal is to check gut bacteria changes, not directly prove better recovery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 220 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 \<=2; Exclusion Criteria: 1. Suspected lack of compliance; 2. Presence of moderate to severe dysphagia; 3. Current participation in other interventional trials or recent participation (within the last 30 days) in an interventional trial; 4. Known allergy or hypersensitivity to trial compounds components or placebo; 5. 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; 6. Malignant diseases including active malignancies with a life expectancy of less than 3 months; 7. Major gastro-intestinal (GI) surgery, chronic inflammatory diseases of the gut and significant GI-neoplasms;
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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