A Study of Probiotics in Patients With Acute Ischemic Stroke

Sponsor
Capital Medical University
Study ID
NCT07651332
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • probiotic supplement OMNi-BiOTiC® SR-9 — DIETARY_SUPPLEMENT
    Each sachet contains approximately 7.5 × 10\^9 live bacteria. Administered orally twice daily.
  • Matching Placebo — OTHER
    Identical in appearance, packaging, and administration method to the probiotic preparation, with no active ingredients.

Study Details

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.

Key Dates

First listed
Jun 16, 2026
Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Probiotic group
    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.
  • Placebo Comparator: Placebo group
    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.

Primary Outcome Measure

Beta diversity of gut microbiota at Day 90±3 (treatment vs. placebo) [ Time Frame: Day 90 ± 3 days ]

Central Contacts

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