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Study on the Efficacy and Safety of Faecalibacterium prausnitzii in Improving Cognitive Function in Patients with Alzheimer's Disease

Study on the Efficacy and Safety of Faecalibacterium prausnitzii in Improving Cognitive Function in Patients with Alzheimer's Disease

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105932
Enrollment
Unknown
Registered
2025-07-15
Start date
2025-07-15
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Alzheimer's Disease

Interventions

Test group:Take 1 capsule of Faecalibacterium prausnitzii every morning on an empty stomach for a total of 28 weeks.
Control group:Take 1 placebo capsule every morning for a total of 28 weeks.

Sponsors

Chaohu Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for AD in DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition); 2. aged 55-80 years; 3. being able to understand the instructions and cooperate in completing the scale assessment; 4. having family members who can sign the informed consent form on behalf of the patient.

Exclusion criteria

Exclusion criteria: 1.having other central nervous system diseases that may cause cognitive impairment, such as stroke, temporal lobe dementia, Parkinson's disease, epilepsy, tumor, encephalitis, etc.; 2.having a history of mental illness that meets the diagnostic criteria in Diagnostic and Statistical Manual of Mental Disorders (DSM-5); 3.cognitive impairment occurring after craniocerebral trauma; 4.having a history of drug abuse, alcohol dependence, poisoning, or exposure to harmful substances such as radiation; 5.having unstable or severe diseases of the heart, lungs, liver, kidneys, or hematopoietic system, poor physical condition, or having major diseases with a very short life expectancy; 6.currently participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Improvement in cognitive function and quality of life;

Secondary

MeasureTime frame
ECG, blood routine, blood biochemical test ;types and quantities of gut microbes;

Countries

China

Contacts

Public ContactZhang Kai

Chaohu Hospital of Anhui Medical University

zhangkai@ahmu.edu.cn+86 189 2110 4636

Outcome results

None listed

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