NCT03636191已完成不适用
The Effect of Lactobacillus Rhamnosus (LGG®) on the Defence Against Pathogens in the Upper Respiratory Tract in Healthy Children - a Single-center, Randomized, Double-blind, Placebo-controlled Study With 16 Weeks Intervention.
Chr Hansen1 个研究点 分布在 1 个国家目标入组 619 人开始时间: 2018年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 619
- 试验地点
- 1
- 主要终点
- The incidence of URTI
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled, two-armed, parallel-group study in healthy children aged 2-6 years. The study will investigate the effect of daily intake of a probiotic on Upper Respiratory Tract Infections (URTI) during a 16-week intervention.
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
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 2-6 years, both inclusive, at the time of informed consent
- •No URTI at the time of inclusion as assessed by a GP
- •Attending day-care with at least 10 children or primary school with at least 10 children in the class for at least 20 hours a week
- •Generally healthy as determined by a GP
- •Guardian consents to participate in the study and to comply with all its procedures
排除标准
- •Any known concomitant chronic infections, chronic systemic diseases, autoimmune diseases (e.g. asthma), immunodeficiency, metabolic diseases, chronic respiratory tract diseases including respiratory allergies and cystic fibrosis, congenital cardiac defects.
- •Suspected or challenge-proved food allergy
- •Use of any prescribed immune suppressive medications at enrolment
- •Use of oral or IV antibiotics in the 1 month before randomisation
- •Not willing to exclude pre/pro/synbiotics during the study
- •Intake of Echinacea, high dose vitamins or Zinc four weeks before and during the study period.
- •Language limitations regarding interviews or questionnaires
- •Participation in other clinical studies in the last 2 months
- •Planning extensive travel (for >1 month) during the duration of the study
结局指标
主要结局
The incidence of URTI
时间窗: 16 weeks
The incidence of URTI measured as the number of URTI episodes diagnosed by a GP according to the prespecified, well-defined criteria, adjusted for sample size.
次要结局
- The Number of days with URTI symptoms(16 weeks)
- The number of days with temperature ≥ 38 °C(16 weeks)
- The incidence of URTI with pathogens(16 weeks)
- The number of subjects with one or more episode of URTI(16 weeks)
- The number of days of absence from daycare or primary school(16 weeks)
- WURSS-K score(16 weeks)
研究者
研究点 (1)
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