Relationship Between Gut Microbiome, Probiotics, and Mild Cognitive Impairment

Last updated: August 5, 2025
Sponsor: Mackay Memorial Hospital
Overall Status: Terminated

Phase

N/A

Condition

Dementia

Memory Problems

Mild Cognitive Impairment

Treatment

PS23 live

Placebo

PS23 heat-treated

Clinical Study ID

NCT04971096
20CT060be
  • Ages 40-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study is to evaluate whether the consumption of probiotics can improve the symptoms of patients with mild cognitive impairment; also evaluate the effects of probiotics on patients' blood, oxidation and stress related indicators.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients who is suffering from Mild Cognitive Impairment.

  2. Clinical Dementia Rating (CDR) 0.5.

  3. Age 40-80 and willing to sign the Informed Consent.

  4. Education level is above the junior high school level.

  5. Healthy control who is eligible judged by PI.

Exclusion

Exclusion Criteria:

  1. Patients on antibiotics within the preceding one month.

  2. Patients using of other probiotic products (sachet, capsule or tablet) within thepreceding two weeks.

  3. Have undergone surgery of liver, bladder, or gastrointestinal tract.

  4. Have current or history of inflammatory bowel disease.

  5. Have history of cancer.

  6. Known allergy to probiotics.

  7. Dementia (MMSE ≤ 23).

  8. Cognitive Impairment caused by head injury.

  9. History of cerebral apocalypse.

  10. Other possible diseases may cause cognitive impairment, such as: Parkinson'sdisease, cervical mass, hydrocephalus or epilepsy.

  11. Severely depressed patients (sick person health questionnaire-9 (PHQ-9) ≥ 20).

  12. Severe anxiety patients (Generalized Anxiety Dosorder 7-Item (GAD-7) ≧ 15).

  13. Undergoing medication treatment for acute illness, Organic psychosis or diagnosed aspsychiatric illness within 3 months or poor control of chronic psychiatric illness.

  14. Undergoing parenteral nutrition.

  15. Not eligible judged by PI.

Study Design

Total Participants: 10
Treatment Group(s): 3
Primary Treatment: PS23 live
Phase:
Study Start date:
April 01, 2022
Estimated Completion Date:
January 16, 2024

Study Description

Mild cognitive impairment (MCI) is the stage between the expected cognitive decline of normal aging and the more serious decline of dementia. It can involve problems with memory, language, thinking and judgment that are greater than normal age-related changes. Probiotics are regarded as active microorganisms. When consumed in sufficient amounts, participants can regulate intestinal flora, intestinal permeability, inflammation and antioxidant reactions in the body, and may produce host health, including delaying disease and regulating metabolic disease progression and prevent complications.

Connect with a study center

  • Mackay Memorial Hospital

    Taipei, 251
    Taiwan

    Site Not Available

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