Effects of Probiotics on Sleep Quality Among Mildly Stressed Adults: A Randomized, Placebo-controlled, Double-blind, Parallel Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Symptoms of insomnia
研究概览
简要总结
The aim of this study is to determine the impact of a probiotic formulation on subjective sleep patterns. It is hypothesized that participants given the probiotics will improve their sleep patterns compared to participants receiving placebo.
详细描述
Participants with symptoms of insomnia and work-related stress will be recruited to participate in a randomized, placebo-controlled, double-blind interventional study for approximately 15 since the signature of the informed consent. Participants will first be seen at the Screening visit when they will be administered several questionnaires to determine eligibility (assessing symptoms of insomnia, work-related stress, psychological distress and other sleep disorders). Participants will receive a 2-week sleep journal and an actigraphy to record their sleep patterns. At visit 2 returning participants will be randomized to receive probiotics or placebo for the following 12 weeks. During this visit, participants will be administered questionnaires assessing sleep quality, work-related productivity, quality of life, and mood. Participants will also be asked to bring to site a stool sample and saliva samples.
Participants will be asked to return at 6 weeks for visit 3. During this visit participants will be administered questionnaires (insomnia, sleep quality, work-related stress and productivity, quality of life, mood and psychological distress).
They will also bring two saliva samples. Two weeks prior to visit 4, participants will be asked to complete another sleep journal and be dispensed another actigraphy which shall be returned at visit 4. Lastly, participants will return on for visit 4 at week 12 in which the same questionnaires as visit 3 will be administered. Participants will also be asked to bring to site another stool sample and two saliva samples.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged between 18 and 65 years-old
- •Scores 8 ≥ in the ISI
- •Having a score higher to 0.8 in the ERI questionnaire
- •Body mass index (BMI) below or equal to
- •Otherwise healthy
- •Working (paid or unpaid) at the same position for at least the past 3 months and plans to have the same position for the duration of the study.
- •Willing to discontinue consumption of probiotics supplements and probiotic fortified products throughout the study
排除标准
- •Presence of unrelated sleep disorders (Obstructive Sleep Apnea and REM Sleep Behavior Disorder) as per questionnaires (STOP BANG and the RBD single question, respectively).
- •Diagnosis of mental disorders (diagnosed by a health professional in the last year, including insomnia) or showing high psychosocial stress assessed by K10 (score equal or above 17).
- •Diabetes (type I and II), blood/bleeding disorders, liver and/or kidney disorders, unstable cardiovascular diseases, neurological diseases (such as, but not limited to Alzheimer's disease, Parkinson's disease, epilepsy), gastrointestinal diseases (such as, but not limited to gastric ulcers, Crohn's disease, ulcerative colitis).
- •Irregular bedtime schedule (schedule resulting in usual bedtime earlier than 8 PM or later than 2 AM or arising time earlier than 4 AM or later than 10 AM).
- •Currently suffering from periodontitis.
- •Pregnancy, planning to be pregnant or currently breastfeeding.
- •Use of medication to improve sleep, such as Zopiclone, Doxepine, Trazodone, Melatonin, any H1-antagonist, antipsychotics.
- •Milk and soy allergy.
- •Lactose intolerance.
结局指标
主要结局
Symptoms of insomnia
时间窗: 12 weeks
Comparison of sleep quality assessed by the Insomnia Severity Index among probiotic versus placebo
次要结局
- Subjective sleep patterns(12 weeks)
- Objective assessment of sleep: Wake after sleep onset (WASO)(12 weeks)
- Work Productivity(12 weeks)
- Mood(12 weeks)
- Levels of sleep-related hormones(12 weeks)
- Objective assessment of sleep: Sleep Latency(12 weeks)
- Work-related stress(12 weeks)
- Symptoms of insomnia (progressive treatment)(6 weeks)
- Objective assessment of sleep: Sleep Efficiency(12 weeks)
- Change on Quality of life(12 weeks)
- Subjective sleep patterns (progressive treatment)(6 weeks)
- Safety of intervention (number of Serious and Adverse events)(12 weeks)