Relationship Between Gut Microbiome, Probiotics, and Mild Cognitive Impairment

Mild Cognitive Impairment (MCI) Clinical Trial

Official title:

Relationship Between Gut Microbiome, Probiotics, and Mild Cognitive Impairment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04971096
• Other study ID #: 20CT060be
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: February 24, 2024

Study information

• Verified date: July 2022
• Source: Mackay Memorial Hospital
• Contact: Shu-I Wu, MD, PhD
• Phone: +886 975835215
• Email: shuiwu[@]g.ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: February 24, 2024
• Est. primary completion date: February 24, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment (MCI)

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
Taiwan	Mackay Memorial Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Mackay Memorial Hospital	Bened Biomedical Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From Baseline to 12 Weeks Assessed
Primary	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.	From Baseline to 12 Weeks Assessed
Secondary	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.	From Baseline to 12 Weeks Assessed
Secondary	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).	From Baseline to 12 Weeks Assessed
Secondary	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).	From Baseline to 12 Weeks Assessed
Secondary	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.	From Baseline to 12 Weeks Assessed
Secondary	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.	From Baseline to 12 Weeks Assessed
Secondary	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.	From Baseline to 12 Weeks Assessed
Secondary	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.	From Baseline to 12 Weeks Assessed
Secondary	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.	From Baseline to 12 Weeks Assessed
Secondary	Change in levels of exploratory blood-based biomarkers for inflammatory and/or oxidative stress changes	Blood-based biomarkers (e.g. IL-6, TNF-a, 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 )	From Baseline to 12 Weeks Assessed
Secondary	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.	From Baseline to 12 Weeks Assessed
Secondary	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.	From Baseline to 12 Weeks Assessed