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TerminatedNo phase

Relationship Between Gut Microbiome, Probiotics, and Mild Cognitive Impairment

Key facts

Who runs it
Mackay Memorial Hospital
Where
Taiwan1 site in 1 countryChoose a country to see its sites
Trial code
Status
Terminated
People taking part
10 people enrolled
Started
1 Apr 2022
Ended
16 Jan 2024
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • PS23 live
  • PS23 heat-treated
  • Placebo
Record updated
8 August 2025
Why it stopped
Difficult to include the patient.

Who can take part

Age
40 years to 80 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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 take part

  • 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
  • Undergoing medication treatment for acute illness, Organic psychosis or diagnosed as psychiatric illness within 3 months or poor control of chronic psychiatric illness
  • Patients on antibiotics within the preceding one month
  • Patients using of other probiotic products (sachet, capsule or tablet) within the preceding two weeks
  • Severely depressed patients (sick person health questionnaire-9 (PHQ-9) ≥ 20)
  • Severe anxiety patients (Generalized Anxiety Dosorder 7-Item (GAD-7) ≧ 15)
  • Undergoing parenteral nutrition
  • Not eligible judged by PI

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • PS23Treatment being tested

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

    Treatment: PS23 live

  • heat-treated PS23Treatment being tested

    PS23 heat-treated, 2 caps daily use.

    Treatment: PS23 heat-treated

  • placeboPlacebo, for comparison

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

  • Healthy ControlNo study treatment, for comparison

    No intervention

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
8 August 2025