NCT05766306已完成2 期
A Randomized, Double-blind, Placebo-controlled, Parallel Study Investigating the Efficacy of a Probiotic Blend on Stress in Adolescents With Moderate Perceived Stress
Lallemand Health Solutions2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年3月15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
- 30
- 试验地点
- 2
- 主要终点
- Change in stress at day 56 from baseline
研究概览
简要总结
The goal of this clinical trial is to test to efficacy of a probiotic blend on stress in adolescents with moderate perceived stress. It is hypothesized that those taking the probiotic blend will have decreased levels of stress compared to those receiving the placebo.
详细描述
Participants in this randomized, double-blind, placebo-controlled, parallel study will be adolescents with moderate perceived stress. Participants will be enrolled in this study for 63 days, with a 56-day intervention period and a 7 day follow-up period. There will be a total of 5 visits: 4 in-person and 1 follow-up phone call.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females between 13 and 17 years, inclusive
- •Individuals of child-bearing potential must have a negative screening urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- •Abstinence or agrees to use contraception if planning to become sexually active
- •Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- •Double-barrier method
- •Intrauterine devices
- •Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- •Vasectomy of partner at least 6 months prior to screening
- •Enrolled in and currently attending school at baseline and for the duration of the study period
- •Individuals with moderate stress as determined by a score of 14-26 on the PSS
- •Does not have an anxiety disorder as determined by QI assessment of the YAM-5
- •Can fluently read and speak English
- •Willing to discontinue consumption of probiotic supplements, probiotic fortified products (e.g., fortified yogurt) and fiber supplements (e.g., Metamucil, Benefiber) for the corresponding washout period indicated in Section 7.3.2 and throughout the study
- •Willingness to maintain current lifestyle habits as much as possible throughout the study including diet, exercise, sleep, and non-pharmacological therapies (e.g., meditation, yoga, breathing exercises)
- •Willingness and ability to complete questionnaires, records and diaries associated with the study and to complete all clinic visits
- •Willingness to provide biological samples (saliva, urine, stool) three times during the study
- •The child and the child's parent(s) or legal guardian(s) to provide voluntary, written, informed assent and consent, respectively, for their child to participate in the study
- •Healthy as determined by medical history as assessed by Q
排除标准
- •Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- •Allergy, sensitivity, or intolerance to the investigational product or placebo ingredients
- •Previous diagnosis or treatment of a mental health disorder or neurodevelopmental disorder, including anxiety disorders (e.g., generalized anxiety disorder, post-traumatic stress disorder, obsessive compulsive disorder, seasonal affective disorder), mood disorders (e.g., major depressive disorder, bipolar disorder) or attention deficit/hyperactivity disorder within the last two years as assessed by the QI
- •Current diagnosis of a sleep disorder (e.g., obstructive sleep apnea, sleep terrors, parasomnia, restless leg syndrome), or a disorder which requires medication that may affect sleep as assessed by the QI
- •Previous diagnosis of neurological diseases (e.g., epilepsy, muscular dystrophy, cerebral palsy) assessed by the QI
- •Currently suffering from periodontitis as assessed by the QI
- •Travelled across 1 or more time zones in the last 3 weeks prior to baseline and/or is anticipating more travel during the study period
- •Current or history of any significant diseases of the gastrointestinal tract (e.g., Crohn's disease, ulcerative colitis, peptic ulcer disease) as assessed by the QI
- •Individuals with an autoimmune disease or are immune compromised
- •Use of medical cannabinoid products as assessed by the QI
- •Use of cannabinoid, tobacco or nicotine-containing products, or alcohol consumption
- •Alcohol or drug abuse within the last 12 months
- •Regular consumption of over-the-counter medications, supplements (e.g., melatonin), foods or drinks that may affect stress or sleep. The participant may be eligible after a washout period prior to their baseline visit and if they agree to discontinue use of the product throughout the study.
- •Current use of prescribed medications that may affect stress, sleep and/or mood
- •Current use of antibiotics. The participant may be eligible after a 30-day washout period prior to their baseline visit
- •Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
- •Individuals who are cognitively impaired and/or unable to give informed consent
- •Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
结局指标
主要结局
Change in stress at day 56 from baseline
时间窗: 56 days
The difference in change from baseline in stress at Day 56 between Probiotic and Placebo measured by the Perceived Stress Scale (PSS). The PSS is a validated and commonly used tool to measure perceived stress. Responses are rated by participants on a 5-point Likert scale. The PSS-10 has been reported to be superior to other versions of the scale and will be used in this study. The total score of PSS-10 ranges between 0-40. Scores between 0-13 are considered low stress, 14-26 are considered moderate stress, and 27-40 are considered high stress.
次要结局
- Change in sleep quality from baseline(56 days)
- Probiotic strain retrieval in stool samples at 28 and 56 days(56 days)
- Untargeted metabolomic analysis on fecal microbiome(56 days)
- Change in stress at day 28 from baseline(28 days)
- Change in sleep-related hormones from baseline(56 days)
- Change in mood from baseline(56 days)
- Change in psychological wellbeing from baseline(56 days)
- Change in daytime sleepiness from baseline(56 days)
- Change in stress-related hormones from baseline(56 days)
- Microbiome composition in stool samples(56 days)
- Change in gastrointestinal symptoms from baseline(56 days)
研究者
研究点 (2)
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