The Effects of Lactobacillus Plantarum PS128 on Depression, Anxiety, Cerebral Rhythms, Autonomic Nervous System Function and Sleep Patterns in Self-Reported Insomniacs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Differences in sleep EEG before and after the consumption of probiotics compared to the placebo group.
研究概览
简要总结
To determine whether PS128 (1) reduces the severity of anxiety and depressive symptoms, (2) adjusts autonomic nervous system functioning, and (3) improves sleep quality.
详细描述
Forty participants with self-reported insomnia between 20 and 40 years old were randomly assigned to two groups, the PS128 and a placebo group, under the double-blind trial. Participants took two capsules with or without PS128 after dinner for 30 days. Study measures included subjective depressive symptoms, anxiety and sleep questionnaires, and miniature polysomnography (miniature-PSG) recordings at baseline and on the 15th and 30th days after taking capsules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) aged 20-40 years old,
- •(2) 18.5 < BMI < 25,
- •(3) BP < 140 mmHg/90 mmHg,
- •(4) PSQI >5, ISI>13,
- •(5) meet the DSM-5 criteria for chronic primary insomnia.
排除标准
- •(1) used other probiotic products within the last two weeks,
- •(2) antibiotic treatment within the last month,
- •(3) taken sleep medication within the last two months or were on long-term use,
- •(4) reported tobacco, alcohol, caffeine or drug addiction,
- •(5) lactic acid bacteria allergy,
- •(6) cancer, cardiovascular disease, psychiatric illness, kidney disease, diabetes mellitus or other sleep disorders,
- •(7) inflammatory bowel disease,
- •(8) hepatobiliary gastrointestinal tract surgery
- •(9) worked the night shift.
结局指标
主要结局
Differences in sleep EEG before and after the consumption of probiotics compared to the placebo group.
时间窗: Baseline, day15 and day30
According to sleep EEG,we can analysis participants' brain waves (alpha,beta,theta,delta) and sleep stages,etc. to evaluate their objective sleep quality.
次要结局
- Differences in The Beck Depression Inventory II (BDI-II) before and after the consumption of probiotics compared to the placebo group.(Baseline, day15 and day30)
- Differences in the Beck Anxiety Inventory (BAI) before and after the consumption of probiotics compared to the placebo group.(Baseline, day15 and day30)
- Differences in The Pittsburgh Sleep Quality Index (PSQI) before and after the consumption of probiotics compared to the placebo group.(baseline and day30)
- Differences in Visual Analogue Scale (VAS) before and after the consumption of probiotics compared to the placebo group.(Baseline, day15 and day30)
- Differences in the State and Trait Anxiety Index (STAI) before and after the consumption of probiotics compared to the placebo group.(Baseline, day15 and day30)
- Differences in the Insomnia Severity Index (ISI) before and after the consumption of probiotics compared to the placebo group.(Baseline, day15 and day30)
- Differences in the Epworth Sleepiness Scale (ESS) before and after the consumption of probiotics compared to the placebo group.(Baseline, day15 and day30)
- Differences in heart rate variability (HRV) before and after the consumption of probiotics compared to the placebo group.(Baseline, day15 and day30)