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Relationship Between Gut Microbiome, Probiotics, and Mild Cognitive Impairment

M

Mackay Memorial Hospital

Status

Enrolling

Conditions

Mild Cognitive Impairment (MCI)

Treatments

Dietary Supplement: Placebo
Dietary Supplement: PS23 live
Dietary Supplement: PS23 heat-treated

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04971096
20CT060be

Details and patient eligibility

About

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.

Full 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.

Enrollment

240 estimated patients

Sex

All

Ages

40 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

240 participants in 4 patient groups, including a placebo group

PS23
Experimental group
Description:
The PS23 belongs to Lactobacillus paracasei group, 2 caps daily use.
Treatment:
Dietary Supplement: PS23 live
heat-treated PS23
Experimental group
Description:
PS23 heat-treated, 2 caps daily use.
Treatment:
Dietary Supplement: PS23 heat-treated
placebo
Placebo Comparator group
Description:
The placebo capsule contains microcrystalline cellulose, 2 caps daily use.
Treatment:
Dietary Supplement: Placebo
Healthy Control
No Intervention group
Description:
No intervention

Trial contacts and locations

1

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Central trial contact

Wan-Lin Chen, Bacholar; Shu-I Wu, MD, PhD

Data sourced from clinicaltrials.gov

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