- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04971096
Relationship Between Gut Microbiome, Probiotics, and Mild Cognitive Impairment
July 10, 2022 updated by: Shu-I Wu, Mackay Memorial Hospital
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
240
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shu-I Wu, MD, PhD
- Phone Number: +886 975835215
- Email: shuiwu@g.ntu.edu.tw
Study Contact Backup
- Name: Wan-Lin Chen, Bacholar
- Phone Number: +886 918830146
- Email: fatty09222002@gmail.com
Study Locations
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-
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Taipei, Taiwan, 251
- Recruiting
- Mackay Memorial Hospital
-
Contact:
- Shu-I Wu, MD, PhD
- Phone Number: 3055 +886-2-88094661
- Email: shuiwu624@gmail.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: PS23
The PS23 belongs to Lactobacillus paracasei group, 2 caps daily use.
|
PS23 belongs to Lactobacillus paracasei group.Probiotic capsules contain 30 billion CFU (colony forming units) of PS23
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EXPERIMENTAL: heat-treated PS23
PS23 heat-treated, 2 caps daily use.
|
The PS23 heat-treated probiotic capsule contain 30 billion of PS23 cells.
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PLACEBO_COMPARATOR: placebo
The placebo capsule contains microcrystalline cellulose, 2 caps daily use.
|
The placebo capsule contains microcrystalline cellulose.
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NO_INTERVENTION: Healthy Control
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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From Baseline to 12 Weeks Assessed
|
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.
|
From Baseline to 12 Weeks Assessed
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Cognitive Abilities Screening Instrument, CASI
Time Frame: From Baseline to 12 Weeks Assessed
|
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.
|
From Baseline to 12 Weeks Assessed
|
Change in Clinical Dementia Rating (CDR)
Time Frame: From Baseline to 12 Weeks Assessed
|
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).
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From Baseline to 12 Weeks Assessed
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Change in Insomnia Severity Index, ISI
Time Frame: From Baseline to 12 Weeks Assessed
|
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).
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From Baseline to 12 Weeks Assessed
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Change in Geriatric Depression Scale, GDS
Time Frame: From Baseline to 12 Weeks Assessed
|
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.
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From Baseline to 12 Weeks Assessed
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Change in Hamilton Anxiety Scale, HAM-A
Time Frame: From Baseline to 12 Weeks Assessed
|
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.
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From Baseline to 12 Weeks Assessed
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Change in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16
Time Frame: From Baseline to 12 Weeks Assessed
|
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.
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From Baseline to 12 Weeks Assessed
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Change in Visual Analogue Scale for GI symptoms (VAS-GI)
Time Frame: From Baseline to 12 Weeks Assessed
|
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.
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From Baseline to 12 Weeks Assessed
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Change in Color Trails Test (CTT)
Time Frame: From Baseline to 12 Weeks Assessed
|
Color Trails Test (CTT) is developed to be free from the influence of language and cultural bias, the CTT assesses sustained attention in adults.
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From Baseline to 12 Weeks Assessed
|
Change in levels of exploratory blood-based biomarkers for inflammatory and/or oxidative stress changes
Time Frame: From Baseline to 12 Weeks Assessed
|
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 )
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From Baseline to 12 Weeks Assessed
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Change in Gut microbiome
Time Frame: From Baseline to 12 Weeks Assessed
|
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.
|
From Baseline to 12 Weeks Assessed
|
Change in WAIS-IV
Time Frame: From Baseline to 12 Weeks Assessed
|
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.
|
From Baseline to 12 Weeks Assessed
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 1, 2022
Primary Completion (ANTICIPATED)
February 24, 2024
Study Completion (ANTICIPATED)
February 24, 2024
Study Registration Dates
First Submitted
June 25, 2021
First Submitted That Met QC Criteria
July 12, 2021
First Posted (ACTUAL)
July 21, 2021
Study Record Updates
Last Update Posted (ACTUAL)
July 12, 2022
Last Update Submitted That Met QC Criteria
July 10, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20CT060be
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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