NCT04125810已完成2 期
A Randomized, Triple-blind, Placebo-controlled, Parallel-groups Clinical Trial to Assess the Safety and Efficacy of Lactobacillus Paracasei (Lpc-37) to Modulate Psychological Stress
Danisco7 个研究点 分布在 2 个国家目标入组 190 人开始时间: 2019年9月2日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 7
- 主要终点
- State Trait Anxiety Inventory (STAI)-state total score
研究概览
简要总结
The purpose of this clinical trial is to determine whether Probiotic can modulate the psychological stress experienced by healthy medical, dental and health science students preparing for university/institute of technology semester examination (s), measured by self-report scales and hypothalamic pituitary adrenal axis activity, compared with placebo.
详细描述
The purpose of this clinical trial is to determine whether Probiotic can modulate the psychological stress experienced by healthy medical, dental and health science students preparing for university/institute of technology semester examination (s), measured by self-report scales and hypothalamic pituitary adrenal axis activity, compared with placebo.
The target group of the proposed study will consist of stress vulnerable / sensitive, healthy male and female adult participants currently enrolled in medical, dental or health science university course that are experiencing psychological stress induced by preparation for university/institute of technology semester examination (s).
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntary, written, informed consent to participate in the study
- •Currently enrolled in medical, dental or health science university/institute of technology course with intention to sit semester examination(s)
- •Male or female aged between 18-40 years (inclusive)
- •Body mass index (BMI) between 18.5 - 29.9 Kg/m2
- •Blood, urine and gastrointestinal safety parameters and blood pressure measurement at baseline indicate they are healthy in the opinion of the Principal Investigator
- •In good general health as estimated by the Principal Investigator, based on medical history (self-reported)
- •Ability of the participant (in the Principal Investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects
- •Ability of the participant (in the Principal Investigator's opinion) to fully comprehend and self-complete all participant reported outcomes (in UK English language)
- •Participant is willing to maintain habitual diet (including caffeine and alcohol), physical activity patterns and smoking habits throughout the intervention period
- •Agreement to comply with the protocol and study restrictions
- •Available for all study visits
- •Females of child-bearing potential required to provide a negative urine pregnancy test and be using effective contraception (e.g. surgically sterilized (tubal ligation or hysterectomy or partner is post-vasectomy, with sterility confirmed) or use an intrauterine device (IUD), a diaphragm or condom combined with contraceptive sponge, foam or jelly, or be using an oral contraceptive for at least 2 cycles before the screening visit (Visit 2). Women who are in same sex relationships or abstaining from sex are not required to take a pregnancy test or be using effective contraception
- •Male participants must agree to use a condom during sexual intercourse from Visit 3 onwards
- •Covered by health insurance system and / or in compliance with the recommendations of National Law in force relating to biomedical research
排除标准
- •Suspected diagnosis of one or more DSM-IV axis 1 disorder(s), including but not limited to: current major depression, anxiety disorder, bipolar spectrum disorder or schizophrenia, as determined by MINI International Neuropsychiatric Interview (MINI) and/or currently diagnosed with one or more DSM-IV axis 1 disorder(s), per Diagnostic and Statistical Manual of Mental Disorders, 4th Edition.
- •Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal (irritable bowel syndrome (IBS), inflammatory bowel disease (IBD)), immunological, metabolic (including diabetes and cardiovascular disease), neurodevelopmental or any condition which contraindicates, in the Principal Investigator's judgement, entry to the study
- •Currently taking (from Visit 1 onwards) or have previously taken (last 4 weeks prior to Visit 1) psychoactive medication (anxiolytics, sedatives, hypnotics, anti-psychotics, anti-depressants, anti-convulsants, centrally acting corticosteroids, opioid pain relievers)
- •Currently taking (from Visit 1 onwards) medication or dietary supplements that the Principal Investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results (e.g. melatonin, St. John's Wort, Rescue® products including Rescue Remedy®, Rescue® Energy, Rescue® Pastilles, Rescue® Pearls, Rescue Sleep® Rescue PlusTM, omega-3 dietary supplements (including fish oil), Cannabidiol (CBD), non-steroidal anti-inflammatory drugs (NSAIDS), over-the-counter sleep medication (not categorized as sedatives, hypnotics or anti-depressants), anti-coagulants, anti-cholinergic drugs or acetylcholinesterase inhibitors, proton pump inhibitors, anti-histamines that cause drowsiness, pseudoephedrine)
- •Recent (within last 4 weeks prior to Visit 1) or ongoing antibiotic therapy
- •Currently taking (from Visit 1 onwards) concentrated sources of probiotics and/or prebiotics other than the provided study products (e.g., probiotic/prebiotic tablets, capsules, drops or powders), including yoghurt / yoghurt drinks
- •Pregnant or lactating female, or pregnancy planned during the intervention period
- •Have self-reported dyslexia
- •History of or current alcohol, drug, or medication abuse (self-reported)
- •Self-declared illicit drug users (including cannabis and cocaine) in the past 1 month prior to Visit 1
- •Excessive alcohol consumption (consuming > 8 units of alcohol for men and > 6 units of alcohol for women in a single session) > 3 times per week for 3 weeks prior to Visit 1
- •Significant change in tobacco, snuff, nicotine or e-cigarette usage habits in the past 1 month before Visit 1 or planned cessation of the use of these products during the intervention period
- •Contraindication to any substance in the investigational product
- •Participation in another study with any investigational product or drug within 60 days of Visit 1
- •Principal Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study
- •Participant under administrative or legal supervision
- •Previous participation in the ChillEx study
结局指标
主要结局
State Trait Anxiety Inventory (STAI)-state total score
时间窗: from baseline to 8 weeks
Absolute change in STAI-state total score between the active versus placebo group
次要结局
- Change in Cortisol awakening response (CAR)(from baseline to 8 weeks)
- Change in perceived stress (Visual Analog Scale (VAS)-stress)(from baseline to 8 weeks)
- Change in DASS-21, depression scale score from baseline (Visit 3) to 8 weeks (Visit 5)(from baseline to 8 weeks)
- Change in DASS-21, anxiety scale score from baseline (Visit 3) to 8 weeks (Visit 5)(from baseline to 8 weeks)
- Change in DASS-21, stress scale score from baseline (Visit 3) to 8 weeks (Visit 5)(from baseline to 8 weeks)
- Change in HADS, depression score from baseline (Visit 3) to 8 weeks (Visit 5)(from baseline to 8 weeks)
- Change in HADS, anxiety score from baseline (Visit 3) to 8 weeks (Visit 5)(from baseline to 8 weeks)
- Change in BL-VAS, alertness score from baseline (Visit 3) to 8 weeks (Visit 5)(from baseline to 8 weeks)
- Change in BL-VAS, contentment score(from baseline to 8 weeks)
- Change in BL-VAS, calmness score(from baseline to 8 weeks)
- Change in PSQI, sleep disturbance score(from baseline to 8 weeks)
- Change in PSQI, daytime dysfunction due to sleepiness score(from baseline to 8 weeks)
- Change in PSQI, sleep efficiency score(from baseline to 8 weeks)
- Change in PSQI, use of medication sleep score(from baseline to 8 weeks)
- Change in PSS, total score from baseline (Visit 3) to 8 weeks (Visit 5)(from baseline to 8 weeks)
- Change in Pittsburgh Sleep Quality Index (PSQI), total score(from baseline to 8 weeks)
- Change in PSQI, duration of sleep score(from baseline to 8 weeks)
- Change in PSQI, sleep latency score(from baseline to 8 weeks)
- Change in PSQI, subjective sleep quality score(from baseline to 8 weeks)
- Change in evening cortisol(from baseline to 8 weeks)
研究者
研究点 (7)
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