An Open Label Trial Evaluating the Efficacy of Lacticaseibacillus Paracasei PS23 on Cognition
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Neuropsychological measures Changes in CANTAB® in 40 subjects after probiotic intervention
Study Overview
Brief Summary
This open label study aims to evaluate whether the consumption of probiotics can improve symptoms and overall quality of life in individuals experiencing cognitive decline symptoms, as well as to evaluate the effects of probiotics on blood-related biomarkers.
Detailed Description
Lacticaseibacillus paracasei PS23 (PS23) is a specific strain of probiotic bacteria known for its potential health benefits, particularly in the context of aging and muscle health. Research suggests that it may improve cognitive function, reduce age-related muscle loss, and modulate the gut microbiota. Probiotic supplements like PS23 are being explored as potential therapeutic agents for age-related cognitive deficits. A prior study showed that PS23 supplementation delayed age-related cognitive decline in mice. Additionally, PS23 has shown antidepressant-like effects and has been found to enhance physical performance and promote muscle recovery following injury.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adults aged 50 to 85 years who self-report experiencing signs of cognitive decline.
- •No prior diagnosis of dementia or Alzheimer's disease (AD).
- •Willing and able to comply with study assessments and requirements, and provide written informed consent.
Exclusion Criteria
- •Use of antibiotics or probiotic powder, capsules, or tablets within the past month.
- •Currently undergoing antibiotic treatment.
- •Known allergy to dairy products.
- •Presence of immunodeficiency or impaired immune function.
- •Diagnosis of small intestinal bacterial overgrowth (SIBO).
- •Determined unsuitable by the investigator, for example, initiation of any new medication or therapy during the study period, particularly those related to memory impairment or cognitive decline.
Arms & Interventions
Probiotics
Lacticaseibacillus paracasei PS23 one capsule daily for 12 weeks
Intervention: Lacticaseibacillus paracasei (Dietary Supplement)
Outcomes
Primary Outcomes
Neuropsychological measures Changes in CANTAB® in 40 subjects after probiotic intervention
Time Frame: baseline to 12 weeks assessed
Cambridge Neuropsychological Test Automated Battery (CANTAB®) includes computerized tests that are correlated to neural networks and have demonstrated high sensitivity in detecting changes in neuropsychological performance.
Secondary Outcomes
- Changes in Chinese version of Trail Making Test (TMT) in 40 subjects after probiotic intervention(baseline to 12 weeks assessed)
- Changes in Chinese version of Stroop color words test(SCWT) in 40 subjects after probiotic intervention(baseline to 12 weeks assessed)
- Changes in Geriatric Depression Scale in 40 subjects after probiotic intervention(baseline to 12 weeks assessed)
- Changes in Anxiety Disorder Assessment (GAD-7) in 40 subjects after probiotic intervention(baseline to 12 weeks assessed)
- Changes in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16 (QLESQ-16) in 40 subjects after probiotic intervention(baseline to 12 weeks assessed)
- Changes in Patient Global Impression scales of Improvement rated by patient （PGI-C) in 40 subjects after probiotic intervention(baseline to 12 weeks assessed)
- Changes in pTau-217 in 40 subjects after probiotic intervention(baseline to 12 weeks assessed)
- Changes in Plasma Aβ40 and Aβ42 in 40 subjects after probiotic intervention(baseline to 12 weeks assessed)
- Changes in Brain-derived neurotrophic factor (BDNF) in 40 subjects after probiotic intervention(baseline to 12 weeks assessed)
- Changes in Glial Fibrillary Acidic Protein (GFAP) in 40 subjects after probiotic intervention(baseline to 12 weeks assessed)
- Changes in Neurofilament Light (NfL) in 40 subjects after probiotic intervention(baseline to 12 weeks assessed)
- Changes in Mandarin Subjective Cognitive Decline Scale (SCDS) in 40 subjects after probiotic intervention(screening, baseline to 12 weeks assessed)
Investigators
Chi-Chang Huang
Dean of Research and Development
National Taiwan Sport University