An Open Label Trial Evaluating the Efficacy of Lacticaseibacillus Paracasei PS23 on Cognition
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Lacticaseibacillus paracasei.
- Кому может быть актуально
- Состояния в реестре: Subjective Cognitive Decline (SCD). Базовые параметры: 50 лет — 85 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Тайвань
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Обзор
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.
Подробное описание
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.
Вмешательства
- Пищевая добавка Lacticaseibacillus paracasei
one capsule daily for 12 weeks
Первичные конечные точки
- Neuropsychological measures Changes in CANTAB® in 40 subjects after probiotic intervention [Срок оценки: baseline to 12 weeks assessed]
Вторичные конечные точки (12)
- Changes in Chinese version of Trail Making Test (TMT) in 40 subjects after probiotic intervention [Срок оценки: baseline to 12 weeks assessed]
- Changes in Chinese version of Stroop color words test(SCWT) in 40 subjects after probiotic intervention [Срок оценки: baseline to 12 weeks assessed]
- Changes in Geriatric Depression Scale in 40 subjects after probiotic intervention [Срок оценки: baseline to 12 weeks assessed]
- Changes in Anxiety Disorder Assessment (GAD-7) in 40 subjects after probiotic intervention [Срок оценки: baseline to 12 weeks assessed]
- Changes in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16 (QLESQ-16) in 40 subjects after probiotic intervention [Срок оценки: baseline to 12 weeks assessed]
- Changes in Patient Global Impression scales of Improvement rated by patient （PGI-C) in 40 subjects after probiotic intervention [Срок оценки: baseline to 12 weeks assessed]
- Changes in pTau-217 in 40 subjects after probiotic intervention [Срок оценки: baseline to 12 weeks assessed]
- Changes in Plasma Aβ40 and Aβ42 in 40 subjects after probiotic intervention [Срок оценки: baseline to 12 weeks assessed]
- Changes in Brain-derived neurotrophic factor (BDNF) in 40 subjects after probiotic intervention [Срок оценки: baseline to 12 weeks assessed]
- Changes in Glial Fibrillary Acidic Protein (GFAP) in 40 subjects after probiotic intervention [Срок оценки: baseline to 12 weeks assessed]
- Changes in Neurofilament Light (NfL) in 40 subjects after probiotic intervention [Срок оценки: baseline to 12 weeks assessed]
- Changes in Mandarin Subjective Cognitive Decline Scale (SCDS) in 40 subjects after probiotic intervention [Срок оценки: screening, baseline to 12 weeks assessed]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
Тайвань · 1 центр
- Graduate Institute of Sports Science, National Taiwan Sport University — Taoyuan
Идентификаторы
NCT: NCT07168824 · IRB-25-061-A2