Relationship Between Gut Microbiome, Probiotics, and Mild Cognitive Impairment

Mackay Memorial Hospital

Status: Enrolling

Conditions: Mild Cognitive Impairment (MCI)

Treatments: Dietary Supplement: Placebo; Dietary Supplement: PS23 live; Dietary Supplement: PS23 heat-treated

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04971096

20CT060be

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

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 criteria

1. Patients on antibiotics within the preceding one month.
2. Patients using of other probiotic products (sachet, capsule or tablet) within the preceding 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's disease, 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 as psychiatric illness within 3 months or poor control of chronic psychiatric illness.
14. Undergoing parenteral nutrition.
15. Not eligible judged by PI.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 4 patient groups, including a placebo group

PS23

Experimental group

Description:

The PS23 belongs to Lactobacillus paracasei group, 2 caps daily use.

Treatment:

Dietary Supplement: PS23 live

heat-treated PS23

Experimental group

Description:

PS23 heat-treated, 2 caps daily use.

Treatment:

Dietary Supplement: PS23 heat-treated

placebo

Placebo Comparator group

Description:

The placebo capsule contains microcrystalline cellulose, 2 caps daily use.

Treatment:

Dietary Supplement: Placebo

Healthy Control

No Intervention group

Description:

No intervention