Relationship Between Gut Microbiome, Probiotics, and Mild Cognitive Impairment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mild Cognitive Impairment (MCI)
- Sponsor
- Mackay Memorial Hospital
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Mini-Mental State Examination, MMSE (end point scare-baseline score)/ Baseline score*100% ≥ 12%
- Status
- Terminated
- Last Updated
- 8 months ago
Overview
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.
Investigators
Shu-I Wu
Senior Attending Physician
Mackay Memorial Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients who is suffering from Mild Cognitive Impairment.
- •Clinical Dementia Rating (CDR) 0.
- •Age 40-80 and willing to sign the Informed Consent.
- •Education level is above the junior high school level.
- •Healthy control who is eligible judged by PI.
Exclusion Criteria
- •Patients on antibiotics within the preceding one month.
- •Patients using of other probiotic products (sachet, capsule or tablet) within the preceding two weeks.
- •Have undergone surgery of liver, bladder, or gastrointestinal tract.
- •Have current or history of inflammatory bowel disease.
- •Have history of cancer.
- •Known allergy to probiotics.
- •Dementia (MMSE ≤ 23).
- •Cognitive Impairment caused by head injury.
- •History of cerebral apocalypse.
- •Other possible diseases may cause cognitive impairment, such as: Parkinson's disease, cervical mass, hydrocephalus or epilepsy.
Outcomes
Primary Outcomes
Mini-Mental State Examination, MMSE (end point scare-baseline score)/ Baseline score*100% ≥ 12%
Time Frame: From Baseline to 12 Weeks Assessed
The Mini-Mental State Exam (MMSE) is a widely used test of cognitive function, The maximum MMSE score is 30 points. A score of 20 to 24 suggests mild dementia, 13 to 20 suggests moderate dementia among the elderly; it includes tests of orientation, attention, memory, language and visual-spatial skills.
Wechsler Memory Scale-III, WMS-III (end point scare-baseline score)/ Baseline score*100% ≥ 12%
Time Frame: From Baseline to 12 Weeks Assessed
The WMS-III has most representative standardization databases to assess memory and make optimal clinical recommendations. The 11 subtests that comprise the index scores average 60 min, ranging from 45 to 75 min, to administer. The time needed to administer the 13 subtests required to generate all of the summary and index scores is 80 min, with a range of 65 to 95 min.
Secondary Outcomes
- Change in Hamilton Anxiety Scale, HAM-A(From Baseline to 12 Weeks Assessed)
- Change in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16(From Baseline to 12 Weeks Assessed)
- Change in Visual Analogue Scale for GI symptoms (VAS-GI)(From Baseline to 12 Weeks Assessed)
- Change in Color Trails Test (CTT)(From Baseline to 12 Weeks Assessed)
- Change in levels of exploratory blood-based biomarkers for inflammatory and/or oxidative stress changes(From Baseline to 12 Weeks Assessed)
- Change in Gut microbiome(From Baseline to 12 Weeks Assessed)
- Change in WAIS-IV(From Baseline to 12 Weeks Assessed)
- Change in Cognitive Abilities Screening Instrument, CASI(From Baseline to 12 Weeks Assessed)
- Change in Clinical Dementia Rating (CDR)(From Baseline to 12 Weeks Assessed)
- Change in Insomnia Severity Index, ISI(From Baseline to 12 Weeks Assessed)
- Change in Geriatric Depression Scale, GDS(From Baseline to 12 Weeks Assessed)