NCT02013934已完成不适用
Benefit and Tolerability of a Probiotic Product in Subjects With Increased Susceptibility to Common Cold
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
- 899
- 试验地点
- 1
- 主要终点
- Severity of cold symptoms
研究概览
简要总结
The objective of this study is to assess the benefit and tolerability of a probiotic product in subjects with increased susceptibility to common cold.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •males and females
- •age 18-70 years
- •increased risk for common cold (at least 4 episodes within 12 months)
- •commitment to adhere to former diet and physical activity
- •commitment not to use any products that may influence the study outcome (e.g. immune suppressants/immune stimulants, including paramedication such as e.g. Echinacea, analgesics/anti-rheumatics, anti-phlogistics, antitussives/expectorants, influenza remedies, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, probiotics) during the study (except for rescue medication, see 7.5)
- •women of child-bearing potential have to agree to use appropriate birth control methods Written consent of the subject to participate is a prerequisite for study participation.
排除标准
- •acute / chronic upper / lower airways disease
- •chronic cough of any origin
- •any allergic reaction that may influence the study outcome (e.g. acute/chronic rhinitis)
- •history of nasal reconstructive surgery
- •presence of nasal ulcers or nasal polyps
- •severe nasal septum deviation or other condition that could cause nasal obstruction
- •congenital or acquired immunodeficiency disease (e.g. HIV infection)
- •Bechterew's disease
- •body temperature above 37.5°C
- •suspected swine flu or influenza
- •vaccination with a vaccine containing an adjuvant within 3 months prior to study start and during the study
- •vaccination with a vaccine not containing an adjuvant within 6 weeks prior to study start and during the study
- •stomach/gastrointestinal diseases
- •serious organ or systemic diseases
- •sleep disorder
- •psychiatric disorders
- •known sensitivity to the ingredients of the investigational product
- •regular intake of products that may influence the study outcome (e.g. immune suppressants/immune stimulants, including paramedication such as e.g. Echinacea, analgesics/anti-rheumatics, anti-phlogistics, antitussives/expectorants, influenza remedies, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, probiotics) within the last 4 weeks prior to study start
- •habitual usage of nasal drops/spray
- •pregnancy or nursing
- •alcohol / drug abuse
- •simultaneous participation in another clinical trial or participation in a clinical trial within the last 30 days
- •insufficient compliance
结局指标
主要结局
Severity of cold symptoms
时间窗: 3 months
Severity of cold symptoms based on the questionnaire WURSS-21 during the cold episodes throughout the study period, in comparison between verum and placebo group
次要结局
- Incidence of common cold episodes(3 months)
研究者
研究点 (1)
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