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A study on the risk warning of white matter hypersignaling with cognitive impairment progression based on gut microbiota and metabolomics and its mediating effect with blood-brain barrier permeability indicators

A study on the risk warning of white matter hypersignaling with cognitive impairment progression based on gut microbiota and metabolomics and its mediating effect with blood-brain barrier permeability indicators

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500111636
Enrollment
Unknown
Registered
2025-11-04
Start date
2025-11-15
Completion date
Unknown
Last updated
2025-11-11

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

Conditions

white matter hypersignaling with cognitive impairment

Interventions

Group without cognitive impairment:None

Sponsors

Gansu Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for white matter hyperintensity that may be of vascular origin in the 2015 Chinese Consensus on the Diagnosis and Treatment of Cerebral Small Vessel Disease, and use head MRI as the diagnostic method. 2. Age between 50-100 years old, male or female, right-handed. 3. Scored using MoCA and MMSE scales. 4. The research subjects and guardians voluntarily participate in this clinical trial, sign the informed consent form, and have good compliance with the study protocol.

Exclusion criteria

Exclusion criteria: 1. Acute cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage; 2. Previous severe anxiety, depression, bipolar disorder and other diseases 3. Confirmed known hereditary cerebrovascular disease; 4. There are clear non-vascular-derived white matter lesions, such as multiple sclerosis, adult leukodysplasia, metabolic encephalopathy, toxic encephalopathy, etc.; 5. Autoimmune diseases, such as lupus erythematosus, rheumatoid arthritis, etc.; 6. Suffering from severe organic diseases, such as malignant tumors, with an expected survival time of < 5 years; 7. The patient is participating in other clinical trials at the same time. 8. Receive drugs to improve cognitive function within 3 months, such as donepezil, memantine, vitamin D, etc.; Cognitive impairment is caused by reversible causes, such as folic acid deficiency, vitamin B12 deficiency or hypothyroidism, lupus encephalopathy, etc. 9. Subjects who cannot cooperate with cognitive examination due to deafness, blindness or other physical diseases; Those who are severely aphasia and agnosia and unable to communicate; 10. Patients with infectious diseases, such as tuberculosis infection, HIV infection, malignant tumors, severe infections, and serious primary diseases of circulatory, respiratory, endocrine, digestive and hematopoietic systems; Severely malnourished; 11. Patients with metal objects built into the head, implantable electronic devices, cochlear implants, surgically implanted pacemakers, artificial heart valves, endovascular stents, cerebral aneurysm clips, or large metal fragments or other foreign bodies in the body; Patients with contraindications to MRI such as claustrophobia; 12. Patients with a history of intracranial organic lesions, infections, head trauma and surgery; 13. Patients with severe alcohol and drug abuse. Alcoholism (more than 70 grams of alcohol per week for women and more than 140 grams per week for men); hormonal drugs or antidepressants; 14. Exclude any other neurological disease causing dementia (including Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, epilepsy, chronic subdural hematoma, and multiple sclerosis, with a history of severe head trauma with persistent neurological deficits or known brain structural abnormalities); 15. Those who meet one of the exclusion criteria for intestinal flora: 1) Systemic antibiotic therapy or continuous use of proton pump inhibitors (omeprazole, lansoprazole, pantoprazole, rabeprazole, etc.) in the three months prior to providing the stool sample. 2) Use corticosteroids orally for intravenous infusion into the nasal cavity and inhalation. 3) Use immunostimulatory drugs. 4) Use immunosuppressants. 5) Unstable dietary habits, consumption of high-dose commercial probiotics (= 108 CFU or organism per day) or discontinuation of the above foods within two weeks. 6) Significant gastrointestinal surgery (except cholecystectomy) within the past five years. 7) Bowel resection at any time. 8) Active uncontrolled gastrointestinal disorders and diseases, including inflammatory bowel disease (IBD), colitis, irritable bowel syndrome (IBS), infectious gastroenteritis, intractable or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent), or chronic constipation. Those who meet any of the above are excluded.

Design outcomes

Primary

MeasureTime frame
Gut microbiota;Metabolism;Indicators related to the permeability of the blood-brain barrier;sleep;Depression;Anxiety; cognitive function;

Countries

China

Contacts

Public ContactYuting Nie

Gansu Provincial Hospital

18810614873@163.com+86 188 1061 8332

Outcome results

None listed

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