Relationship Between Gut Microbiome, Probiotics, and Mild Cognitive Impairment

NCT04971096 | Terminated

• 1 other identifier: 20CT060be
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment (MCI)

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (11)

• 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

• Change in Hamilton Anxiety Scale, HAM-A

  From Baseline to 12 Weeks Assessed

Study Arms (4)

PS23

EXPERIMENTAL

The PS23 belongs to Lactobacillus paracasei group, 2 caps daily use.

Dietary Supplement: PS23 live

heat-treated PS23

EXPERIMENTAL

PS23 heat-treated, 2 caps daily use.

Dietary Supplement: PS23 heat-treated

placebo

PLACEBO COMPARATOR

The placebo capsule contains microcrystalline cellulose, 2 caps daily use.

Dietary Supplement: Placebo

Healthy Control

NO INTERVENTION

No intervention

Interventions

PS23 live DIETARY_SUPPLEMENT

PS23 belongs to Lactobacillus paracasei group.Probiotic capsules contain 30 billion CFU (colony forming units) of PS23

PS23

PS23 heat-treated DIETARY_SUPPLEMENT

The PS23 heat-treated probiotic capsule contain 30 billion of PS23 cells.

heat-treated PS23

Placebo DIETARY_SUPPLEMENT

The placebo capsule contains microcrystalline cellulose.

placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mackay Memorial Hospital: lead
• Bened Biomedical Co., Ltd.: collaborator

Study Sites (1)

Mackay Memorial Hospital

Taipei, 251, Taiwan

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double blind randomized control study
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Attending Physician

Model Details: 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.

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 21, 2021
• Study Start: April 1, 2022
• Primary Completion: January 16, 2024
• Study Completion: January 16, 2024
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

TW (1)