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Clinical evaluation of Bifidobacterium breve CCFM1179 on improving cognitive ability and analysis of intestinal flora in individuals with mild cognitive impairment

Clinical evaluation of Bifidobacterium breve CCFM1179 on improving cognitive ability and analysis of intestinal flora in individuals with mild cognitive impairment

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097969
Enrollment
Unknown
Registered
2025-02-28
Start date
2025-02-20
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Mild cognitive impairment

Interventions

Bifidobacterium breve CCFM1179 group:Bifidobacterium breve CCFM1179
placebo group:placebo
health group:None

Sponsors

Yixing People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 89 Years

Inclusion criteria

Inclusion criteria: 1. Age 60-89 years, no restriction on gender; 2. Meets MCI clinical criteria (DSM-5); 3. Written informed consent provided for participation in the study;

Exclusion criteria

Exclusion criteria: 1. Subsequent complications caused by Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, progressive supranuclear palsy, epilepsy, multiple sclerosis, brain infection or head trauma; A history of major depression or bipolar disorder, alcohol or other substance abuse; The discovery of multiple infarcts, brain tumors, or subdural hematoma; Cognitive impairment due to vitamin B12 or folate deficiency; Neurosyphilis; Thyroid dysfunction; 2. Severe cases (cerebrovascular, heart, liver, kidney, gastrointestinal tract, endocrine metabolism, infectious diseases), digestive system cancer, gastrointestinal resection and inflammatory bowel disease; 3. Heavy use of drugs (antibiotics, intestinal disease drugs, laxatives, antidiarrheals) and health foods, supplements (lactic acid bacteria, bifidobacterium, lactic acid bacteria, low Glycan, dietary fiber); 4. Obvious abnormal blood pressure and blood tests; Severe anemia; Allergies to drugs and food; Heavy smokers and drinkers; Irregular lifestyle, such as diet type, sleep time; 5. Severe diabetes treated with anti-dementia drugs, psychoactive drugs, and insulin; 6. Participate in any other new drug research for AD; Participating in another new drug study; 7. Deemed unqualified by the principal researcher;

Design outcomes

Primary

MeasureTime frame
Fecal flora;Brain-derived neurotrophic factor; Fecal flora genomics;

Secondary

MeasureTime frame
Blood routine examination;Blood glucose;Blood fat;

Countries

China

Contacts

Public ContactJie Li

Yixing People's Hospital

staff1185@yxph.com+86 138 6171 9426

Outcome results

None listed

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