Clinical trial NCT04971096: Relationship Between Gut Microbiome, Probiotics, and Mild Cognitive Impairment
Official title: Relationship Between Gut Microbiome, Probiotics, and Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment (MCI)
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Bened Biomedical Co., Ltd.
First posted: 2021-07-21
Enrollment: 240
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participates in three groups, 60 patients in each group. One group of patients will be given PS23, one will be given heat-treated PS23 and the other one will be given placebo.
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mini-Mental State Examination, MMSE (end point scare-baseline score)/ Baseline score*100% ≥ 12%
timeFrame: From Baseline to 12 Weeks Assessed
measure: Wechsler Memory Scale-III, WMS-III (end point scare-baseline score)/ Baseline score*100% ≥ 12%
timeFrame: From Baseline to 12 Weeks Assessed
Secondary outcomes:
measure: Change in Cognitive Abilities Screening Instrument, CASI
timeFrame: From Baseline to 12 Weeks Assessed
measure: Change in Clinical Dementia Rating (CDR)
timeFrame: From Baseline to 12 Weeks Assessed
measure: Change in Insomnia Severity Index, ISI
timeFrame: From Baseline to 12 Weeks Assessed
measure: Change in Geriatric Depression Scale, GDS
timeFrame: From Baseline to 12 Weeks Assessed
measure: Change in Hamilton Anxiety Scale, HAM-A
timeFrame: From Baseline to 12 Weeks Assessed
measure: Change in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16
timeFrame: From Baseline to 12 Weeks Assessed
measure: Change in Visual Analogue Scale for GI symptoms (VAS-GI)
timeFrame: From Baseline to 12 Weeks Assessed
measure: Change in Color Trails Test (CTT)
timeFrame: From Baseline to 12 Weeks Assessed
measure: Change in levels of exploratory blood-based biomarkers for inflammatory and/or oxidative stress changes
timeFrame: From Baseline to 12 Weeks Assessed
measure: Change in Gut microbiome
timeFrame: From Baseline to 12 Weeks Assessed
measure: Change in WAIS-IV
timeFrame: From Baseline to 12 Weeks Assessed
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
Study officials:
References: