Ischemic StrokePhase 2PRO-STROKENCT07651332
A Study of Probiotics in Patients With Acute Ischemic Stroke
A Phase 2 study testing probiotic supplement OMNi-BiOTiC® SR-9 in people with Ischemic Stroke, run by Capital Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- probiotic supplement OMNi-BiOTiC® SR-9
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
- 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;
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Placebo-Controlled, Double-Blind, Phase 2 Trial of Probiotic Supplementation in Acute Ischemic Stroke
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.
Read the detailed description
Ischemic stroke induces a rapid and sustained systemic inflammatory response that contributes to secondary brain injury, post-stroke complications, and long-term functional outcome. In addition to well-characterized neuroinflammatory mechanisms, increasing evidence indicates that stroke profoundly alters the gut microbiota through autonomic dysfunction, reduced intestinal motility, altered permeability, and frequent exposure to antibiotics and hospital-related stressors. This stroke-induced dysbiosis has been linked to systemic immune activation, impaired immune homeostasis, and increased susceptibility to infections, all of which negatively affect recovery after stroke.
Experimental studies have demonstrated that the composition and functional capacity of the gut microbiota influence ischemic brain injury and post-stroke inflammation. Alterations in microbial community structure can modulate peripheral immune responses, including myeloid cell activation and cytokine production, and affect levels of microbiota-derived metabolites such as short-chain fatty acids (SCFAs). SCFAs, including acetate, propionate, and butyrate, exert immunomodulatory effects by regulating innate and adaptive immune responses and maintaining intestinal barrier integrity. Reduced SCFA availability has been associated with enhanced systemic inflammation and adverse neurological outcomes in experimental stroke models.
Clinical observations further support the relevance of the gut-brain axis in stroke. Patients with acute ischemic stroke exhibit rapid changes in gut microbiome composition, reduced microbial diversity, and shifts in specific taxa that correlate with stroke severity, systemic inflammation, and functional outcome. However, whether targeted modulation of the gut microbiota after stroke can reproducibly alter microbial community structure and downstream biological processes in humans remains unclear. Existing clinical studies of probiotics and synbiotics have shown anti-inflammatory effects in various non-neurological conditions, but data from adequately powered randomized controlled trials in acute ischemic stroke are lacking.
The probiotic formulation OMNi-BiOTiC® SR-9 contains multiple well-characterized bacterial strains combined with a prebiotic matrix designed to support bacterial viability and metabolic activity. This formulation has demonstrated immunomodulatory properties and a favorable safety profile in previous clinical applications. Administered early after stroke, probiotic supplementation represents a low-risk, non-invasive strategy to counteract stroke-associated dysbiosis, stabilize gut microbial community structure, and potentially restore microbiota-derived metabolic and immune signaling.
Given the complexity and inter-individual variability of the human gut microbiome, global measures of microbial community composition, such as beta diversity, represent sensitive and biologically meaningful endpoints to capture probiotic-induced changes. Assessing microbiome beta diversity at 90 days allows sufficient time for microbial ecosystem restructuring and stabilization following acute stroke and hospitalization, while still reflecting effects initiated during the early post-stroke phase.
Therefore, this randomized, placebo-controlled phase 2 trial is designed to evaluate whether daily oral administration of OMNi-BiOTiC® SR-9 for 90 days can induce measurable changes in gut microbiome beta diversity in patients with acute ischemic stroke. Secondary objectives address clinical outcome, specific microbial taxa, and circulating SCFAs to provide complementary mechanistic insights and inform the design of future outcome-driven trials.
- Conditions
- Ischemic Stroke
- Being tested
- probiotic supplement OMNi-BiOTiC® SR-9, Matching Placebo
- Keywords
- ischemic stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotic supplement OMNi-BiOTiC® SR-9Dietary supplement
Each sachet contains approximately 7.5 × 10^9 live bacteria. Administered orally twice daily.
Matching PlaceboOther
Identical in appearance, packaging, and administration method to the probiotic preparation, with no active ingredients.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Subjects receive the probiotic supplement OMNi-BiOTiC® SR-9 orally twice daily, one sachet each time, with each sachet containing approximately 7.5 × 10^9 live bacteria. Receives: Dietary Supplement: probiotic supplement OMNi-BiOTiC® SR-9 |
| Placebo group | Placebo comparator | Subjects receive placebo orally twice daily, one sachet each time, consisting of an equal volume of starch, with appearance, packaging, and administration method identical to the probiotic preparation. Receives: Other: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 90 ± 3 days
Secondary outcomes (7)
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.
Measured: Day 90 ± 3 days
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.
Measured: Baseline to Day 90 ± 3 days
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.
Measured: Baseline to Day 90 ± 3 days
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.
Measured: Baseline and Day 90 ± 3 days
EQ-5D-5L at day 90
EQ-5D-5L assesses health-related quality of life across 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), higher scores indicate better health. EQ-VAS ranges from 0 to 100, higher scores indicate better self-perceived health.
Measured: Day 90 ± 3 days
Barthel Index at day 90
The Barthel Index is an ordinal scale consisting of 10 activities of daily living (including feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, bed-to-chair transfer, ambulation, and stair climbing). Total scores range from 0 to 100, with higher scores indicating greater functional independence and better prognosis.
Measured: Day 90 ± 3 days
Safety Outcomes
The safety outcome is the number of reported adverse events (AEs) and serious adverse events (SAEs) in the verum group compared to the placebo group. All events will be assessed for severity, causality, and relevance, and reported in accordance with regulatory guidelines.
Measured: Baseline to Day 90 ± 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
- Investigators
- Xunming Ji, PhD, MD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651332
- Sponsor's protocol ID
- PRO-STROKE
- Acronym
- PRO-STROKE
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled, Double-Blind, Phase 2 Trial of Probiotic Supplementation in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07651332
- Acronym / sponsor ID
- PRO-STROKE / PRO-STROKE
- Conditions
- Ischemic Stroke
- Keywords
- ischemic stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Ischemic stroke induces a rapid and sustained systemic inflammatory response that contributes to secondary brain injury, post-stroke complications, and long-term functional outcome. In addition to well-characterized neuroinflammatory mechanisms, increasing evidence indicates that stroke profoundly alters the gut microbiota through autonomic dysfunction, reduced intestinal motility, altered permeability, and frequent exposure to antibiotics and hospital-related stressors. This stroke-induced dysbiosis has been linked to systemic immune activation, impaired immune homeostasis, and increased susceptibility to infections, all of which negatively affect recovery after stroke.
Experimental studies have demonstrated that the composition and functional capacity of the gut microbiota influence ischemic brain injury and post-stroke inflammation. Alterations in microbial community structure can modulate peripheral immune responses, including myeloid cell activation and cytokine production, and affect levels of microbiota-derived metabolites such as short-chain fatty acids (SCFAs). SCFAs, including acetate, propionate, and butyrate, exert immunomodulatory effects by regulating innate and adaptive immune responses and maintaining intestinal barrier integrity. Reduced SCFA availability has been associated with enhanced systemic inflammation and adverse neurological outcomes in experimental stroke models.
Clinical observations further support the relevance of the gut-brain axis in stroke. Patients with acute ischemic stroke exhibit rapid changes in gut microbiome composition, reduced microbial diversity, and shifts in specific taxa that correlate with stroke severity, systemic inflammation, and functional outcome. However, whether targeted modulation of the gut microbiota after stroke can reproducibly alter microbial community structure and downstream biological processes in humans remains unclear. Existing clinical studies of probiotics and synbiotics have shown anti-inflammatory effects in various non-neurological conditions, but data from adequately powered randomized controlled trials in acute ischemic stroke are lacking.
The probiotic formulation OMNi-BiOTiC® SR-9 contains multiple well-characterized bacterial strains combined with a prebiotic matrix designed to support bacterial viability and metabolic activity. This formulation has demonstrated immunomodulatory properties and a favorable safety profile in previous clinical applications. Administered early after stroke, probiotic supplementation represents a low-risk, non-invasive strategy to counteract stroke-associated dysbiosis, stabilize gut microbial community structure, and potentially restore microbiota-derived metabolic and immune signaling.
Given the complexity and inter-individual variability of the human gut microbiome, global measures of microbial community composition, such as beta diversity, represent sensitive and biologically meaningful endpoints to capture probiotic-induced changes. Assessing microbiome beta diversity at 90 days allows sufficient time for microbial ecosystem restructuring and stabilization following acute stroke and hospitalization, while still reflecting effects initiated during the early post-stroke phase.
Therefore, this randomized, placebo-controlled phase 2 trial is designed to evaluate whether daily oral administration of OMNi-BiOTiC® SR-9 for 90 days can induce measurable changes in gut microbiome beta diversity in patients with acute ischemic stroke. Secondary objectives address clinical outcome, specific microbial taxa, and circulating SCFAs to provide complementary mechanistic insights and inform the design of future outcome-driven trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: probiotic supplement OMNi-BiOTiC® SR-9Subjects receive the probiotic supplement OMNi-BiOTiC® SR-9 orally twice daily, one sachet each time, with each sachet containing approximately 7.5 × 10^9 live bacteria. |
| Placebo group | Placebo comparator | Other: Matching PlaceboSubjects receive placebo orally twice daily, one sachet each time, consisting of an equal volume of starch, with appearance, packaging, and administration method identical to the probiotic preparation. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probiotic supplement OMNi-BiOTiC® SR-9Each sachet contains approximately 7.5 × 10^9 live bacteria. Administered orally twice daily. | Dietary supplement | Probiotic group |
| Matching PlaceboIdentical in appearance, packaging, and administration method to the probiotic preparation, with no active ingredients. | Other | Placebo group |
Primary outcome
Beta diversity of gut microbiota at Day 90±3 (treatment vs. placebo)
Time frame: Day 90 ± 3 days
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.
7 secondary outcomes
Modified Rankin Scale (mRS) score at Day 90±3
Time frame: Day 90 ± 3 days
Change in modified Rankin Scale (mRS) score from baseline to Day 90±3
Time frame: Baseline to Day 90 ± 3 days
Changes in gut microbiota diversity and relative abundance of Prevotella copri at Day 90±3
Time frame: Baseline to Day 90 ± 3 days
Serum concentrations of short-chain fatty acids (SCFAs) at Day 90±3
Time frame: Baseline and Day 90 ± 3 days
EQ-5D-5L at day 90
Time frame: Day 90 ± 3 days
Barthel Index at day 90
Time frame: Day 90 ± 3 days
Safety Outcomes
Time frame: Baseline to Day 90 ± 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xunming Ji, PhD, MD principal investigator
Xuanwu Hospital, Beijing
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing probiotic supplement OMNi-BiOTiC® SR-9 in people with Ischemic Stroke, run by Capital Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lan Liu, PhD (8683911991, liulan1815@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beta diversity of gut microbiota at Day 90±3 (treatment vs. placebo) (time frame: Day 90 ± 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.