A Study of Probiotics in Patients With Acute Ischemic Stroke

NCT07651332 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: PRO-STROKE
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ischemic Stroke

Keywords

ischemic stroke

Outcome Measures

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.

  Day 90 ± 3 days

Secondary Outcomes (7)

• Modified Rankin Scale (mRS) score at Day 90±3

  Day 90 ± 3 days

• Change in modified Rankin Scale (mRS) score from baseline to Day 90±3

  Baseline to Day 90 ± 3 days

• Changes in gut microbiota diversity and relative abundance of Prevotella copri at Day 90±3

  Baseline to Day 90 ± 3 days

• Serum concentrations of short-chain fatty acids (SCFAs) at Day 90±3

  Baseline and Day 90 ± 3 days

• EQ-5D-5L at day 90

  Day 90 ± 3 days

Study Arms (2)

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.

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.

Other: Matching Placebo

Interventions

probiotic supplement OMNi-BiOTiC® SR-9 DIETARY_SUPPLEMENT

Each sachet contains approximately 7.5 × 10\^9 live bacteria. Administered orally twice daily.

Probiotic group

Matching Placebo OTHER

Identical in appearance, packaging, and administration method to the probiotic preparation, with no active ingredients.

Placebo group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Capital Medical University: lead

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xunming Ji, PhD, MD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lan Liu, PhD

CONTACT

8683911991; liulan1815@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 16, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06