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A randomized controlled and prospective clinical study of probiotics in the treatment of arteriosclerotic cerebrovascular disease

A randomized controlled and prospective clinical study of probiotics in the treatment of arteriosclerotic cerebrovascular disease

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047078
Enrollment
Unknown
Registered
2021-06-07
Start date
2021-06-01
Completion date
Unknown
Last updated
2022-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cerebral small vessel disease

Interventions

Experimental group:Probiotic+standard treatment
Control group:standard treatment

Sponsors

The Third Affiliated Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 50 years; 2. There is at least one of the following vascular risk factors for atherosclerosis: smoking (10 cigarettes/day, smoking age >= 10 years), BMI> 28, hypertension, diabetes, impaired fasting blood sugar or impaired glucose tolerance , Hyperlipidemia, hyperhomocysteinemia, coronary heart disease, symptomatic stroke; 3. There are at least one of the following common acute or chronic clinical symptoms (syndrome) of cerebrovascular disease: TIA, acute lacunar syndrome (pure motor hemiparesis, pure sensory stroke, ataxia hemiparesis, sensory Motor stroke, dysarthria-clumsy hand syndrome, etc.), cognitive decline, gait or postural balance disorder, vascular parkinsonism, mental or affective disorders (anxiety, depression, etc.), sleep disorders, urine Sphincter dysfunction; 4. For acute symptoms, there are anatomical-related responsible lesions on MRI, DWI indicates that the lesion is less than 20mm (axial), and T1, T2 or FLAIR indicates that the lesion is 3-15mm in the non-acute stage; 5. Without obvious clinical symptoms, there are lacunar lesions (=2) or other two or more common imaging features of CSVD (microbleeds, enlarged perivascular space) ) can also be included.

Exclusion criteria

Exclusion criteria: 1. The intracranial and extracranial arteries are more than 50% stenosis or have previously undergone carotid endarterectomy; 2. TOAST classification suggests (probably) cardiogenic stroke; 3. On MRI, there are cortical infarcts or subcortical infarcts with a diameter of more than 1.5 cm (non-acute stage); there are white matter hyperintensities caused by other diseases such as multiple sclerosis or leukodystroph; 4. Diagnosis of central nervous system diseases such as hemorrhage or other pathological brain diseases (brain trauma, epilepsy, encephalitis, hydrocephalus, brain tumors) based on MRI; other systemic diseases (liver and kidney insufficiency, tumors, etc.); 5. People who are unable to cooperate with alcoholism, drug addiction, history of mental illness or physical disability (including severe aphasia).

Design outcomes

Primary

MeasureTime frame
Montreal Cognitive Assessment Scale Rate;

Secondary

MeasureTime frame
gait scale;high density electroencephalogram;Cranial magnetic resonance scan;Intestinal flora;Neurotransmitters;

Countries

China

Contacts

Public ContactLu Zhengqi

The Third Affiliated Hospital of Sun Yat-Sen University

lzq1828@aliyun.com+86 13570102668

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026