Tests sodium oligomannate to prevent thinking problems after ischemic stroke
Tests a drug against placebo to prevent thinking decline in people after stroke.
Key facts
- Who runs it
- Nanfang Hospital, Southern Medical University
- Where
- Guangzhou, ChinaSee the site
- Trial code
- Registry title
- Efficacy and Safety of Sodium Oligomannate in the Prevention of PSCI
- Status
- Recruiting
- People taking part
- 116 people, planned
- Started
- 1 Apr 2023
- Planned end
- 31 Dec 2025
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Sodium oligomannate
- Placebo capsule
- Record updated
- 13 June 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18-80 who had a first ischemic stroke less than 7 days ago and now show mild thinking and memory problems.
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- First ischemic stroke confirmed by CT or MR, less than 7 days since onset, NIHSS score 15 or lower, clear consciousness, and a MoCA score below 22 after correction.
- Earlier treatment
- People who used antibiotics in the 3 months before the stroke cannot join.
- Biomarker or test result
- A stool sample collected within 7 days of onset is needed.
Main reasons for not taking part
- Cannot take part in thinking and memory tests (for example, because of consciousness, vision or hearing problems)
- Other serious diseases such as brain tumour, epilepsy, neurodegenerative disease, or severe heart, liver, kidney or blood disease
- Used antibiotics in the 3 months before the stroke
- History of alcohol abuse, drug use or serious mental illness, including major depression (HAMD > 10)
- No stool sample collected within 7 days of onset
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in China
- Nanfang Hospital, Southern Medical UniversityGuangzhou, ChinaContact: Department of Neurology, Nanfang HospitalTaking people
About the trial
What the trial wants to find out
Post-stroke cognitive impairment (PSCI) is a common complication of stroke, and seriously affect the quality of survival and the survival time in patients with stroke, PSCI is still lack of effective prevention and treatment measures, the study found that gut microbiota are closely associated with stroke and cognitive diseases, sodium oligomannate can improve cognitive function of mild-to-moderate alzheimer's disease (AD) , The Expert Consensus 2021 on the Management of Post-stroke cognitive impairment states that the role of sodium oligomannate in PSCI needs to be investigated in large sample clinical trials. This study intends to explore the efficacy and safety of sodium oligomannate in the prevention of PSCI in patients with acute ischemic stroke and cognitive impairment, so as to provide a potential intervention for the prevention of PSCI.
The 2 groups in the trial
- Intervention groupTreatment being tested
Subjects randomized to the trial group will receive sodium oligomannate 450mg twice daily for 24 weeks.
Treatment: Sodium oligomannate
- Control groupPlacebo, for comparison
Subjects randomized to the control group will receive a 450mg placebo capsule twice daily for 24 weeks that has exactly the same appearance and smell as the Intervention group.
Treatment: Placebo capsule
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Efficacy and Safety of Sodium Oligomannate in the Prevention of Post-stroke Cognitive Impairment in Patients With Ischemic Stroke:a Randomized, Double-blind, Exploratory Controlled Study
- Plain-language title
- Tests sodium oligomannate to prevent thinking problems after ischemic strokeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05545605, who can take part
- Record updated
- 13 June 2025