Mild Cognitive Impairment (MCI)NCT04971096
Relationship Between Gut Microbiome, Probiotics, and Mild Cognitive Impairment
A study testing PS23 live and PS23 heat-treated in people with Mild Cognitive Impairment (MCI), run by Mackay Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- PS23 live and PS23 heat-treated
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2022to 16 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- PS23 live, PS23 heat-treated, Placebo
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PS23 liveDietary supplement
PS23 belongs to Lactobacillus paracasei group.Probiotic capsules contain 30 billion CFU (colony forming units) of PS23
PS23 heat-treatedDietary supplement
The PS23 heat-treated probiotic capsule contain 30 billion of PS23 cells.
PlaceboDietary supplement
The placebo capsule contains microcrystalline cellulose.
| Study group | Role | What they receive |
|---|---|---|
| PS23 | Experimental | The PS23 belongs to Lactobacillus paracasei group, 2 caps daily use. Receives: Dietary Supplement: PS23 live |
| heat-treated PS23 | Experimental | PS23 heat-treated, 2 caps daily use. Receives: Dietary Supplement: PS23 heat-treated |
| placebo | Placebo comparator | The placebo capsule contains microcrystalline cellulose, 2 caps daily use. Receives: Dietary Supplement: Placebo |
| Healthy Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Baseline to 12 Weeks Assessed
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.
Measured: From Baseline to 12 Weeks Assessed
Secondary outcomes (11)
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.
Measured: From Baseline to 12 Weeks Assessed
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).
Measured: From Baseline to 12 Weeks Assessed
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).
Measured: From Baseline to 12 Weeks Assessed
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.
Measured: From Baseline to 12 Weeks Assessed
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.
Measured: From Baseline to 12 Weeks Assessed
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.
Measured: From Baseline to 12 Weeks Assessed
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.
Measured: From Baseline to 12 Weeks Assessed
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.
Measured: From Baseline to 12 Weeks Assessed
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 )
Measured: From Baseline to 12 Weeks Assessed
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.
Measured: From Baseline to 12 Weeks Assessed
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.
Measured: From Baseline to 12 Weeks Assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start1 Apr 2022
- Primary completion16 Jan 2024
- Study completion16 Jan 2024
Why it stopped: Difficult to include the patient.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bened Biomedical Co., Ltd.
- Responsible party
- Principal investigator, Shu-I Wu, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971096
- Sponsor's protocol ID
- 20CT060be
- Status last verified
- Aug 2025
- First submitted
- 25 Jun 2021
- Last updated
- 8 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Gut Microbiome, Probiotics, and Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04971096
- Acronym / sponsor ID
- 20CT060be
- Conditions
- Mild Cognitive Impairment (MCI)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficult to include the patient.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Collaborators
- Bened Biomedical Co., Ltd.
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 16 Jan 2024 (actual)
- Study completion
- 16 Jan 2024 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| PS23 | Experimental | Dietary Supplement: PS23 liveThe PS23 belongs to Lactobacillus paracasei group, 2 caps daily use. |
| heat-treated PS23 | Experimental | Dietary Supplement: PS23 heat-treatedPS23 heat-treated, 2 caps daily use. |
| placebo | Placebo comparator | Dietary Supplement: PlaceboThe placebo capsule contains microcrystalline cellulose, 2 caps daily use. |
| Healthy Control | No intervention | –No intervention |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PS23 livePS23 belongs to Lactobacillus paracasei group.Probiotic capsules contain 30 billion CFU (colony forming units) of PS23 | Dietary supplement | PS23 |
| PS23 heat-treatedThe PS23 heat-treated probiotic capsule contain 30 billion of PS23 cells. | Dietary supplement | heat-treated PS23 |
| PlaceboThe placebo capsule contains microcrystalline cellulose. | Dietary supplement | placebo |
Primary outcome
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.
11 secondary outcomes
Change in Cognitive Abilities Screening Instrument, CASI
Time frame: From Baseline to 12 Weeks Assessed
Change in Clinical Dementia Rating (CDR)
Time frame: From Baseline to 12 Weeks Assessed
Change in Insomnia Severity Index, ISI
Time frame: From Baseline to 12 Weeks Assessed
Change in Geriatric Depression Scale, GDS
Time frame: From Baseline to 12 Weeks Assessed
Change in Hamilton Anxiety Scale, HAM-A
Time frame: From Baseline to 12 Weeks Assessed
Change in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16
Time frame: From Baseline to 12 Weeks Assessed
Change in Visual Analogue Scale for GI symptoms (VAS-GI)
Time frame: From Baseline to 12 Weeks Assessed
Change in Color Trails Test (CTT)
Time frame: 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
Change in Gut microbiome
Time frame: From Baseline to 12 Weeks Assessed
Change in WAIS-IV
Time frame: From Baseline to 12 Weeks Assessed
Results and safety
The study was stopped early (reason given: Difficult to include the patient.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PS23 live and PS23 heat-treated in people with Mild Cognitive Impairment (MCI), run by Mackay Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficult to include the patient.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination, MMSE (end point scare-baseline score)/ Baseline score*100% ≥ 12% (time frame: From Baseline to 12 Weeks Assessed). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.