An Open Label Trial Evaluating the Efficacy of Lacticaseibacillus Paracasei PS23 on Cognition
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lacticaseibacillus paracasei.
- Who it may be relevant to
- Registry conditions: Subjective Cognitive Decline (SCD). Basic parameters: 50 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Dietary supplement Lacticaseibacillus paracasei
one capsule daily for 12 weeks
Primary outcome measures
- Neuropsychological measures Changes in CANTAB® in 40 subjects after probiotic intervention [Time frame: baseline to 12 weeks assessed]
Secondary outcome measures (12)
- Changes in Chinese version of Trail Making Test (TMT) in 40 subjects after probiotic intervention [Time frame: baseline to 12 weeks assessed]
- Changes in Chinese version of Stroop color words test(SCWT) in 40 subjects after probiotic intervention [Time frame: baseline to 12 weeks assessed]
- Changes in Geriatric Depression Scale in 40 subjects after probiotic intervention [Time frame: baseline to 12 weeks assessed]
- Changes in Anxiety Disorder Assessment (GAD-7) in 40 subjects after probiotic intervention [Time frame: baseline to 12 weeks assessed]
- Changes in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16 (QLESQ-16) in 40 subjects after probiotic intervention [Time frame: baseline to 12 weeks assessed]
- Changes in Patient Global Impression scales of Improvement rated by patient （PGI-C) in 40 subjects after probiotic intervention [Time frame: baseline to 12 weeks assessed]
- Changes in pTau-217 in 40 subjects after probiotic intervention [Time frame: baseline to 12 weeks assessed]
- Changes in Plasma Aβ40 and Aβ42 in 40 subjects after probiotic intervention [Time frame: baseline to 12 weeks assessed]
- Changes in Brain-derived neurotrophic factor (BDNF) in 40 subjects after probiotic intervention [Time frame: baseline to 12 weeks assessed]
- Changes in Glial Fibrillary Acidic Protein (GFAP) in 40 subjects after probiotic intervention [Time frame: baseline to 12 weeks assessed]
- Changes in Neurofilament Light (NfL) in 40 subjects after probiotic intervention [Time frame: baseline to 12 weeks assessed]
- Changes in Mandarin Subjective Cognitive Decline Scale (SCDS) in 40 subjects after probiotic intervention [Time frame: screening, baseline to 12 weeks assessed]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Taiwan · 1 center
- Graduate Institute of Sports Science, National Taiwan Sport University — Taoyuan
Identifiers
NCT: NCT07168824 · IRB-25-061-A2