An Open Label Trial Evaluating the Efficacy of Lacticaseibacillus Paracasei PS23 on Cognition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Neuropsychological measures Changes in CANTAB® in 40 subjects after probiotic intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Probiotics
Lacticaseibacillus paracasei PS23 one capsule daily for 12 weeks
干预措施: Lacticaseibacillus paracasei (Dietary Supplement)
结局指标
主要结局
Neuropsychological measures Changes in CANTAB® in 40 subjects after probiotic intervention
时间窗: 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.
次要结局
- 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)
研究者
Chi-Chang Huang
Dean of Research and Development
National Taiwan Sport University