Sodium oligomannate to prevent cognitive decline after ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled, single-center study that enrolled 116 adults with a first ischemic stroke to compare sodium oligomannate versus placebo over a 6-month period. Participants were randomized 1:1 and received study medication or matching placebo, with safety checks at 4, 12, and 24 weeks and efficacy assessments at 12 and 24 weeks. Eligible patients were enrolled within 7 days of stroke onset, were able to cooperate with cognitive testing, and had MoCA scores below the study cutoff after education correction. The trial focuses on preventing post-stroke cognitive impairment by targeting gut microbiota-related mechanisms suggested in prior Alzheimer’s research.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1.The first occurrence of ischemic stroke, which met the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018, was confirmed by CT or MR; 2. The onset of illness was less than 7 days after admission, aged 18-80 years; 3. Clear consciousness, able to cooperate with cognitive and other tests, NIHSS score ≤15; 4. Before onset, the patient's cognitive level was normal, daily life and social activities were normal; 5. Stay in the current place of residence for more than 3 years; 6. With cognitive assessment, MoCA \< 22 (years of education \< 12, +1) after correction, and signed the informed consent.

Exclusion Criteria:

* 1.Unable to cooperate with neuropsychological examination due to various reasons (such as consciousness disorders, vision disorders, hearing disorders, etc.); 2. Combined with other diseases (such as intracranial mass, demyelinating disease, intracranial infection, neurodegenerative disease, epilepsy, severe heart, liver, kidney, blood system or other system diseases, etc.); 3. Used antibiotics 3 months before onset; 4. A history of alcohol abuse, drug use, or serious mental illness (including major depression (HAMD \> 10)) before onset of illness, 5. No stool was collected within 7 days of onset.

Where it's running

• Nanfang Hospital, Southern Medical University
  Guangzhou, Baiyun, China Recruiting
• Nanfang Hospital,Southern Medical University
  Guangzhou, Guangdong, China Not yet recruiting

Study contacts

• Study coordinator: Jia Yin, M.D
• Email: jiajiayin@139.com
• Phone: 13802964883

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.