Relationship Between Gut Microbiome, Probiotics, and Mild Cognitive Impairment
NCT ID: NCT04971096
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
10 participants
INTERVENTIONAL
2022-04-01
2024-01-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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PS23
The PS23 belongs to Lactobacillus paracasei group, 2 caps daily use.
PS23 live
PS23 belongs to Lactobacillus paracasei group.Probiotic capsules contain 30 billion CFU (colony forming units) of PS23
heat-treated PS23
PS23 heat-treated, 2 caps daily use.
PS23 heat-treated
The PS23 heat-treated probiotic capsule contain 30 billion of PS23 cells.
placebo
The placebo capsule contains microcrystalline cellulose, 2 caps daily use.
Placebo
The placebo capsule contains microcrystalline cellulose.
Healthy Control
No intervention
No interventions assigned to this group
Interventions
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PS23 live
PS23 belongs to Lactobacillus paracasei group.Probiotic capsules contain 30 billion CFU (colony forming units) of PS23
PS23 heat-treated
The PS23 heat-treated probiotic capsule contain 30 billion of PS23 cells.
Placebo
The placebo capsule contains microcrystalline cellulose.
Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
80 Years
ALL
Yes
Sponsors
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Bened Biomedical Co., Ltd.
INDUSTRY
Mackay Memorial Hospital
OTHER
Responsible Party
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Shu-I Wu
Senior Attending Physician
Locations
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Mackay Memorial Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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20CT060be
Identifier Type: -
Identifier Source: org_study_id
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