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Dynamic changes of intestinal flora and microbial-gut-brain axis intervention monitoring in intracranial tuberculosis patients with mild cognitive impairment based on functional magnetic resonance imaging

Dynamic changes of intestinal flora and microbial-gut-brain axis intervention monitoring in intracranial tuberculosis patients with mild cognitive impairment based on functional magnetic resonance imaging

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106259
Enrollment
Unknown
Registered
2025-07-21
Start date
2023-12-28
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

mild cognitive impairment of intracranial tuberculosis

Interventions

Treatment group:Drink a bottle of probiotic-rich yogurt daily
Control group:None

Sponsors

Beijing Chest Hospital,Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Diagnostic criteria for intracranial tuberculosis: (1) The diagnosis needs to meet the following requirements. At least one of the following clinical manifestations: headache, irritability, vomiting, fever, neck stiffness, convulsions, local nerve damage, disturbance of consciousness, lethargy, and one or more of the following: Acid-fast bacilli found in cerebrospinal fluid (CSF); CSF was positive for mycobacterium tuberculosis culture. CSF was positive for Mycobacterium tuberculosis nucleic acid. ? Pathological changes of tuberculosis were found in the brain or spinal cord, and acid-fast staining was positive, with clinical manifestations and corresponding CSF changes. According to the "Tuberculosis Laboratory Testing Procedures" (Zhao Yanlin et al., 2015), ?-interferon release test, acid-fast staining, mycobacterium culture, and Genexpert MTB/RIF nucleic acid detection were performed. 2. Diagnostic criteria for MCI: The Simple Mental State Scale (MMSE) and the Chinese version of the Montreal Cognitive Assessment Scale (MoCA) were used for cognitive function assessment. The total score of both scales is 30 points, and when using MoCA to assess cognitive function, the number of years of education <12 years needs to be added 1 point. MoCA<26, MMSE score 21-26, MCI; When grouping, MMSE and MoCA scores were not consistent with MMSE scores, and MCI clinical symptoms were used to identify the patients: (1) Relatives and other informed persons confirmed that the patients had memory decline as the main manifestation, while other cognitive functions were relatively intact or slightly impaired; (2) Daily life is not affected, can not meet the diagnostic criteria of dementia; (3) Except for other diseases that cause brain decline.

Exclusion criteria

Exclusion criteria: 1. Alzheimer's disease, vascular dementia, Lewy body dementia and other causes of dementia; 2. endocrine and metabolic diseases, major depression and other causes of cognitive dysfunction; 3. Cerebrovascular diseases, brain trauma, epilepsy and other nervous system diseases and mental system diseases; 4. Alcoholism or the use of glucocorticoids and drugs that affect brain function; 5. Patients with organic diseases such as heart, liver and kidney and known tumors; 6. diabetes mellitus; 7. Women during pregnancy and lactation,women of childbearing age with long-term oral contraceptive medication; 8. Non-tuberculosis infection,surgery and other stress in last month; 9. Patients with contraindications for MRI examination after metal material implantation surgery; 10. Allergy to dairy products.

Design outcomes

Primary

MeasureTime frame
fMRI features;Brain network characteristics;Predictive efficacy of intestinal flora and other indicators in potentially beneficial and non-beneficial intracranial tuberculosis patients with MCI (AUC value);Analysis results of serum differential metabolites and metabolic pathways enrichment;Analysis results of urine differential metabolites and metabolic pathways enrichment;Analysis results of faeces differential metabolites and metabolic pathways enrichment;Analysis results of salivary differential metabolites and metabolic pathways enrichment;

Countries

China

Contacts

Public ContactHou Dailun

Beijing Chest Hospital,Capital Medical University

hou.dl@mail.ccmu.edu.cn+86 10 8950 9456

Outcome results

None listed

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