Evaluating the Potential of Probiotic Supplementation Sleep Quality
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Insomnia severity index, ISI
研究概览
简要总结
This study aims to evaluate the feasibility of probiotics in improving sleep indicators through clinical human studies. Previous animal experiments have confirmed that Limosilactob acillus fermentum PS150 and heat-treated Lactobacillus fermentum HT-PS150 strains have the effect of improving sleep. 90 subjects will be recruited, 45 in each group. They will be given either HT-PS150 or placebo for 8 weeks and their blood, urine, saliva and questionnaire will be evaluated.
详细描述
The most important function of sleep is to restore physical energy lost after activities during the day, and to adjust and reorganize people's emotions, behavior, and cognitive memory. The average adult sleeps about 7 to 8 hours. Good sleep quality has a great impact on the performance of work and study during the day. If a person does not get enough sleep for a long time, it is easy to suffer from memory loss, emotional instability and other phenomena. It will also affect the operation of the immune system and easily lead to colds and illnesses. The following statements are often complained by sleep disorder patient: 1. Difficulty falling asleep. 2. Difficulty maintaining sleep, often waking up suddenly in the middle of sleep or having difficulty falling back to sleep once woken up. 3. Waking up too early and having trouble falling back to sleep. This study aims to evaluate the feasibility of probiotics in improving sleep indicators through clinical human studies. Previous animal experiments have confirmed that Limosilactob acillus fermentum PS150 and heat-treated Lactobacillus fermentum HT-PS150 strains have the effect of improving sleep.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 to 60 years old
- •Pittsburgh Sleep Quality Scale score is greater than or equal to 5
- •Insomnia Severity Scale (ISI less than 22 points)
- •Subjects need to have a regular daily routine (no night shift work)
排除标准
- •Have used antibiotics or probiotic products in powder, capsule or tablet form within one month
- •Are taking drugs that may affect sleep (for example: sleeping pills, antipsychotic drugs, corticosteroids, antihistamines, stimulants, etc.) or undergoing hormonal treatment (including birth control pills)
- •Those who are taking traditional Chinese medicine or western medicine to treat serious acute diseases
- •Patients with uncontrolled high blood pressure or diabetes, a history of cancer, and mental illness
- •Those with a diagnosis of other sleep disorders besides insomnia (narcolepsy, restless legs, sleep apnea, etc.)
- •People who are allergic to probiotic products
- •Pregnant or breastfeeding
- •Alcohol, tobacco and coffee addicts
- •Have carried out long-distance travel or work across time zones in the past month and the next two months
- •Those who have participated in other interventional clinical studies in the past three months
- •Those who are judged by the moderator to be unsuitable to participate in the research
研究组 & 干预措施
probiotics
heat-treated Limosilactobacillus fermentum PS150
干预措施: heat-treated Limosilactobacillus fermentum (Dietary Supplement)
placebo
microcrystalline cellulose
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Insomnia severity index, ISI
时间窗: From baseline to 8 weeks assessed
The ISI is a 7-item patient-reported outcome measure (PROM) assessing the nature, severity, and impact of insomnia on a 5-point Likert scale to rate each item from 0 (no problem) to 4 (very severe problem).
Pittsburgh sleep quality index, PSQI
时间窗: From baseline to 8 weeks assessed
The Pittsburgh Sleep Quality Index contains 19 self-rated questions which measures seven aspects of sleep: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points (0 indicates no difficulty, while 3 indicates severe difficulty). The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality).
次要结局
- Change in GABA in both blood and saliva(From baseline to 8 weeks assessed)
- Changes in Interleukin-6 (IL-6) in saliva(From baseline to 8 weeks assessed)
- Change in Serotonin in both blood and saliva(From baseline to 8 weeks assessed)
- Patient Global Impression scales of Improvement rated by patient（PGI-C）(From baseline to 8 weeks assessed)
- Sleep quality(From baseline to 8 weeks assessed)
- Change in 6 sulfatoxymelatonin in urine(From baseline to 8 weeks assessed)
- Change in Norepinephrine in both blood and urine(From baseline to 8 weeks assessed)
- Change in Generalised Anxiety Disorder Assessment (GAD-7)(From baseline to 8 weeks assessed)
- Change in Visual Analogue Scale-GI (VAS-GI)(From baseline to 8 weeks assessed)
- Change in Orexin in both blood and saliva(From baseline to 8 weeks assessed)
- Total sleep time(From one week before baseline to 8 weeks assessed)
- Change in Melatonin in both blood and saliva(From baseline to 8 weeks assessed)
- Change in Cortisol in both blood and saliva(From baseline to 8 weeks assessed)
- Change in Depression Score Patient Health Questionnaire (PHQ-9)(From baseline to 8 weeks assessed)
- Change in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16(From baseline to 8 weeks assessed)
- Change in Total Antioxidant Capacity , TAC(From baseline to 8 weeks assessed)
- Change in Gut microbiome(From baseline to 8 weeks assessed)
研究者
Chi-Chang Huang
Dean of Research and Development Office
National Taiwan Sport University