Back to resultsRelationship Between Gut Microbiome, Probiotics, and Mild Cognitive Impairment
Primary Purpose
Mild Cognitive Impairment (MCI)
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
PS23 live
PS23 heat-treated
Placebo
Sponsored by
About this trial
This is an interventional other trial for Mild Cognitive Impairment (MCI)
Eligibility Criteria
Inclusion Criteria:
- Patients who is suffering from Mild Cognitive Impairment.
- Clinical Dementia Rating (CDR) 0.5.
- 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.
- Severely depressed patients (sick person health questionnaire-9 (PHQ-9) ≥ 20).
- Severe anxiety patients (Generalized Anxiety Dosorder 7-Item (GAD-7) ≧ 15).
- Undergoing medication treatment for acute illness, Organic psychosis or diagnosed as psychiatric illness within 3 months or poor control of chronic psychiatric illness.
- Undergoing parenteral nutrition.
- Not eligible judged by PI.
Sites / Locations
- Mackay Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
No Intervention
Arm Label
PS23
heat-treated PS23
placebo
Healthy Control
Arm Description
The PS23 belongs to Lactobacillus paracasei group, 2 caps daily use.
PS23 heat-treated, 2 caps daily use.
The placebo capsule contains microcrystalline cellulose, 2 caps daily use.
No intervention
Outcomes
Primary Outcome Measures
Mini-Mental State Examination, MMSE (end point scare-baseline score)/ Baseline score*100% ≥ 12%
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%
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 Outcome Measures
Change in Cognitive Abilities Screening Instrument, CASI
The Cognitive Abilities Screening Instrument (CASI) has a score range of 0 to 100 and provides quantitative assessment on attention, concentration, orientation, short-term memory, long-term memory, language abilities, visual construction, list-generating fluency, abstraction, and judgment, higher scores mean a better outcome.
Change in Clinical Dementia Rating (CDR)
The CDR is a global summary measure designed to identify the overall severity of dementia. Six different content areas are rated individually (memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care). CDR is calculated on the basis of testing six different cognitive and behavioral domains such as memory, orientation, judgment and problem solving, community affairs, home and hobbies performance, and personal care. The CDR is based on a scale of 0-3: no dementia (CDR = 0), questionable dementia (CDR = 0.5), MCI (CDR = 1), moderate cognitive impairment (CDR = 2), and severe cognitive impairment (CDR = 3).
Change in Insomnia Severity Index, ISI
The ISI is a rating tool used to gauge of sleeping. Higher values represent a worse outcome. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Change in Geriatric Depression Scale, GDS
The Geriatric Depression Scale (GDS) is a self-report measure of depression in older adults. Users respond in a "Yes/No" format. The GDS was originally developed as a 30-item instrument. Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
Change in Hamilton Anxiety Scale, HAM-A
The HAM-A was one of the first rating scales developed to measure the severity of anxiety symptoms, and is still widely used today in both clinical and research settings. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Change in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16
The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16 is a valid, reliable self-report instrument for assessing quality of life. The minimum raw score on the Q-LES-Q-16 is 14, and the maximum score is 70, higher scores mean a better outcome.
Change in Visual Analogue Scale for GI symptoms (VAS-GI)
Visual Analogue Scale for GI symptoms, VAS-GI (visual analogue scale, VAS 0-10) was designed to measure the response of symptoms and well-being in patients after taking PS23, total score is 0-100, higher scores mean a worse outcome.
Change in Color Trails Test (CTT)
Color Trails Test (CTT) is developed to be free from the influence of language and cultural bias, the CTT assesses sustained attention in adults.
Change in levels of exploratory blood-based biomarkers for inflammatory and/or oxidative stress changes
Blood-based biomarkers (e.g. IL-6, TNF-α, GDF-15, Adiponectin, EGF, BDNF, MDA, Nitric oxide (NO) , GSH, TAC, Ghrelin, Cystatin C , Hs-CRP, HbA1c, Glucose (AC), Triglycerides (TG), LDL, HDL , Insulin, miRNA and total cholesterol )
Change in Gut microbiome
The gut microbiome plays important roles in both the maintenance of health and the pathogenesis of disease. Stool will be examined before and after probiotics.
Change in WAIS-IV
WAIS-IV is composed of 10 core subtests and five supplemental subtests, with the 10 core subtests yielding scaled scores that sum to derive the Full Scale IQ. With the WAIS-IV, the verbal/performance IQ scores from previous versions were removed and replaced by the index scores.
Full Information
NCT ID
NCT04971096
First Posted
June 25, 2021
Last Updated
July 10, 2022
Sponsor
Mackay Memorial Hospital
Collaborators
Bened Biomedical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04971096
Brief Title
Relationship Between Gut Microbiome, Probiotics, and Mild Cognitive Impairment
Official Title
Relationship Between Gut Microbiome, Probiotics, and Mild Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
February 24, 2024 (Anticipated)
Study Completion Date
February 24, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mackay Memorial Hospital
Collaborators
Bened Biomedical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment (MCI)
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
This is a double blind randomized control study
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PS23
Arm Type
Experimental
Arm Description
The PS23 belongs to Lactobacillus paracasei group, 2 caps daily use.
Arm Title
heat-treated PS23
Arm Type
Experimental
Arm Description
PS23 heat-treated, 2 caps daily use.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
The placebo capsule contains microcrystalline cellulose, 2 caps daily use.
Arm Title
Healthy Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
PS23 live
Intervention Description
PS23 belongs to Lactobacillus paracasei group.Probiotic capsules contain 30 billion CFU (colony forming units) of PS23
Intervention Type
Dietary Supplement
Intervention Name(s)
PS23 heat-treated
Intervention Description
The PS23 heat-treated probiotic capsule contain 30 billion of PS23 cells.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
The placebo capsule contains microcrystalline cellulose.
Primary Outcome Measure Information:
Title
Mini-Mental State Examination, MMSE (end point scare-baseline score)/ Baseline score*100% ≥ 12%
Description
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.
Time Frame
From Baseline to 12 Weeks Assessed
Title
Wechsler Memory Scale-III, WMS-III (end point scare-baseline score)/ Baseline score*100% ≥ 12%
Description
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.
Time Frame
From Baseline to 12 Weeks Assessed
Secondary Outcome Measure Information:
Title
Change in Cognitive Abilities Screening Instrument, CASI
Description
The Cognitive Abilities Screening Instrument (CASI) has a score range of 0 to 100 and provides quantitative assessment on attention, concentration, orientation, short-term memory, long-term memory, language abilities, visual construction, list-generating fluency, abstraction, and judgment, higher scores mean a better outcome.
Time Frame
From Baseline to 12 Weeks Assessed
Title
Change in Clinical Dementia Rating (CDR)
Description
The CDR is a global summary measure designed to identify the overall severity of dementia. Six different content areas are rated individually (memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care). CDR is calculated on the basis of testing six different cognitive and behavioral domains such as memory, orientation, judgment and problem solving, community affairs, home and hobbies performance, and personal care. The CDR is based on a scale of 0-3: no dementia (CDR = 0), questionable dementia (CDR = 0.5), MCI (CDR = 1), moderate cognitive impairment (CDR = 2), and severe cognitive impairment (CDR = 3).
Time Frame
From Baseline to 12 Weeks Assessed
Title
Change in Insomnia Severity Index, ISI
Description
The ISI is a rating tool used to gauge of sleeping. Higher values represent a worse outcome. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Time Frame
From Baseline to 12 Weeks Assessed
Title
Change in Geriatric Depression Scale, GDS
Description
The Geriatric Depression Scale (GDS) is a self-report measure of depression in older adults. Users respond in a "Yes/No" format. The GDS was originally developed as a 30-item instrument. Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
Time Frame
From Baseline to 12 Weeks Assessed
Title
Change in Hamilton Anxiety Scale, HAM-A
Description
The HAM-A was one of the first rating scales developed to measure the severity of anxiety symptoms, and is still widely used today in both clinical and research settings. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Time Frame
From Baseline to 12 Weeks Assessed
Title
Change in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16
Description
The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16 is a valid, reliable self-report instrument for assessing quality of life. The minimum raw score on the Q-LES-Q-16 is 14, and the maximum score is 70, higher scores mean a better outcome.
Time Frame
From Baseline to 12 Weeks Assessed
Title
Change in Visual Analogue Scale for GI symptoms (VAS-GI)
Description
Visual Analogue Scale for GI symptoms, VAS-GI (visual analogue scale, VAS 0-10) was designed to measure the response of symptoms and well-being in patients after taking PS23, total score is 0-100, higher scores mean a worse outcome.
Time Frame
From Baseline to 12 Weeks Assessed
Title
Change in Color Trails Test (CTT)
Description
Color Trails Test (CTT) is developed to be free from the influence of language and cultural bias, the CTT assesses sustained attention in adults.
Time Frame
From Baseline to 12 Weeks Assessed
Title
Change in levels of exploratory blood-based biomarkers for inflammatory and/or oxidative stress changes
Description
Blood-based biomarkers (e.g. IL-6, TNF-α, GDF-15, Adiponectin, EGF, BDNF, MDA, Nitric oxide (NO) , GSH, TAC, Ghrelin, Cystatin C , Hs-CRP, HbA1c, Glucose (AC), Triglycerides (TG), LDL, HDL , Insulin, miRNA and total cholesterol )
Time Frame
From Baseline to 12 Weeks Assessed
Title
Change in Gut microbiome
Description
The gut microbiome plays important roles in both the maintenance of health and the pathogenesis of disease. Stool will be examined before and after probiotics.
Time Frame
From Baseline to 12 Weeks Assessed
Title
Change in WAIS-IV
Description
WAIS-IV is composed of 10 core subtests and five supplemental subtests, with the 10 core subtests yielding scaled scores that sum to derive the Full Scale IQ. With the WAIS-IV, the verbal/performance IQ scores from previous versions were removed and replaced by the index scores.
Time Frame
From Baseline to 12 Weeks Assessed
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients who is suffering from Mild Cognitive Impairment.
Clinical Dementia Rating (CDR) 0.5.
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.
Severely depressed patients (sick person health questionnaire-9 (PHQ-9) ≥ 20).
Severe anxiety patients (Generalized Anxiety Dosorder 7-Item (GAD-7) ≧ 15).
Undergoing medication treatment for acute illness, Organic psychosis or diagnosed as psychiatric illness within 3 months or poor control of chronic psychiatric illness.
Undergoing parenteral nutrition.
Not eligible judged by PI.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shu-I Wu, MD, PhD
Phone
+886 975835215
Email
shuiwu@g.ntu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Wan-Lin Chen, Bacholar
Phone
+886 918830146
Email
fatty09222002@gmail.com
Facility Information:
Facility Name
Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
251
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu-I Wu, MD, PhD
Phone
+886-2-88094661
Ext
3055
Email
shuiwu624@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Relationship Between Gut Microbiome, Probiotics, and Mild Cognitive Impairment
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