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The impact of probiotic supplementation on cognitive functions and related physiological factors in elderly individuals with mild cognitive impairment

The impact of probiotic supplementation on cognitive functions and related physiological factors in elderly individuals with mild cognitive impairment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084594
Enrollment
Unknown
Registered
2024-05-21
Start date
2024-05-31
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

cognitive impairment

Interventions

Probiotic Powder Intervention Group:Participants in the probiotic powder intervention group will receive one packet of probiotic powder daily. Each packet contains 2 grams, comprising Lactobacillus pl
Control group:One bag of placebo powder is supplemented every day. Except for probiotics, the placebo used in this study has the same raw materials as probiotics powder. Each bag contains 2g of maltod

Sponsors

School of Public Health, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age between 55 and 80 years old; 2. Initial screening: Mini Montreal Cognitive Assessment (mini-MOCA) = 5 points or Ascertain Dementia 8-item informant questionnaire (AD8) = 3 points; 3. Detailed screening: Montreal Cognitive Assessment (MOCA) < 26 points; 4. Sufficient visual and auditory capabilities to undergo cognitive function tests.

Exclusion criteria

Exclusion criteria: 1. Allergic to probiotics; 2. Other potential diseases that could cause cognitive impairment or diagnosed with a disease associated with cognitive dysfunction, such as dementia, Parkinson's disease, stroke, cervical mass, hydrocephalus, or epilepsy; 3. Using medication for organic psychosis or poorly controlled psychiatric or chronic mental illness in the past three months, including antipsychotics, tricyclic antidepressants, and other drugs that may affect alertness and cognitive ability; 4. History of severe liver, kidney, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, metabolic diseases, or cancer; 5. History of major gastrointestinal surgeries such as gastrectomy, gastrointestinal anastomosis, intestinal resection (excluding appendicitis); 6. Patients with severe anxiety or depression; 7. History of alcohol abuse or drug dependency; 8. Participation in another clinical study within three months prior to the study screening; 9. Regular use of prebiotics or probiotic supplements within one month prior to the study screening; 10. Expected absence from Shanghai for a long duration (one month or more) during the intervention period; 11. Deemed ineligible based on screening data or by the researchers.

Design outcomes

Primary

MeasureTime frame
Cognitive Function Tests;

Secondary

MeasureTime frame
anthropometric indices;physical function examination;wearable devices to monitor blood glucose and physical activity.;dietary information;demographic information;brain MRI;blood biochemical indicators;genetic;metabolomics;circadian rhythm;environment pollutants;gut microbiota;nutrients;

Countries

China

Contacts

Public ContactLiang Sun

School of Public Health, Institute of Nutrition, Fudan University

sun_liang@fudan.edu.cn+86 21 5423 7087

Outcome results

None listed

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