NCT04931082已完成不适用
A Randomized, Double-blinded, Placebo-controlled, Parallel Clinical Trial of a Probiotic on Stress and Cognitive Function in Healthy Adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Probi AB
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Determine whether intake of probiotics reduce perceived stress
研究概览
简要总结
The effect of probiotics on stress and cognitive function in healthy adults with moderate stress
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing to participate in the study and comply with its procedures.
- •Be able to give written informed consent.
- •Be between 21 and 50 years.
- •Have moderate stress, as measured on Cohen's Perceived Stress Scale (PSS).
- •Are not suffering from depression or anxiety, confirmed by a Hospital Anxiety and Depression Scale (HADS) score.
- •Are not regularly consuming probiotics for at least 4 weeks prior to the Screening Visit.
- •Is in general good health, as determined by the investigator.
排除标准
- •Current diagnosis of currently active irritable bowel syndrome (IBS), according to Rome IV criteria.
- •Chronic intestinal disease, immunodeficiency disorder or immunosuppressive treatment.
- •Known gluten intolerance, lactose intolerance, milk protein allergy.
- •Intake of antibiotics within four weeks prior to the Screening Visit.
- •Hypersensitivity to any of the ingredients in the Investigational Product (IP).
- •Previous (within 5 years) or ongoing psychiatric illness.
- •Consumption of systemic psychotropics, rheumatoid drugs, steroid drugs or creams containing cortisone.
- •Regular consumption of asthma medications.
- •History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk if participating in the study, or influence the results or the participant´s ability to participate in the study.
- •Investigator considers the participant unlikely to comply with study procedures, restrictions, and requirements.
- •Any disease, that by the investigator's judgement, could interfere with the intestinal barrier function.
- •Participation in other clinical trials involving Investigational Product consumption in the last month.
- •Desire and/or plans on changing current diet and/or exercise regime during the participation of this trial.
- •Participants who are pregnant, breastfeeding, or wish to become pregnant during the study.
- •Participants currently of childbearing potential, but not using an effective method of contraception.
- •Have a malignant disease or any concomitant end-stage organ disease, which, in the Investigator's judgment, contraindicates participation in the study.
- •Individuals who, in the opinion of the investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the trial.
- •Taking any supplements or vitamins notably known to affect cognitive function. Vitamin D and calcium supplements permitted if on a stable dose for the previous 3 months.
- •History of heavy caffeinated beverage consumption (>400 mg caffeine/day) within past 2 weeks prior to the Screening Visit.
结局指标
主要结局
Determine whether intake of probiotics reduce perceived stress
时间窗: 12 weeks
Perceived stress will be evaluated with Cohen's Perceived Stress Scale (PSS) (min 0, max 40)
次要结局
未报告次要终点
研究者
研究点 (1)
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