NCT03457688已完成不适用
Double-blind, Randomized Placebo-controlled, Multi-center Trial Investigating the Effect of Prebiotic Inulin-type Fructans on Infectious Incidence in Children Aged 3 to 6 Years
Beneo-Institute0 个研究点目标入组 850 人开始时间: 2016年9月19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
- 850
- 主要终点
- Number of febrile infectious episodes diagnosed by paediatrician
研究概览
简要总结
The study aims to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on the reduction of the number of febrile infections diagnosed by the paediatrician in children.
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
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is healthy at the time of pre-examination
- •Subject is aged 3-6 years at the time of pre-examination
- •Subject attends a kindergarten at the time of pre-examination
排除标准
- •Suffering from current infection or has suffered from infection in previous 7 days
- •Intake of antibiotics and/or laxatives in the previous 14 days prior to start of the intervention
- •children with known gastrointestinal disease or malformation
- •children with congenital or acquired immunodeficiency
- •children with food intolerance, food allergy
- •children that regularly consume (more than 3 times per week) probiotic products or a food supplement containing prebiotics
- •children involved in any clinical or food study within the preceding 6 months
结局指标
主要结局
Number of febrile infectious episodes diagnosed by paediatrician
时间窗: 6 months period
次要结局
- Duration of febrile infectious episodes diagnosed by the paediatrician(6 months period)
- Duration of episodes with symptoms of illnesses indicating a viral or bacterial infection(6 months period)
- Number of days of medication use (including prescribed/ non-prescribed medication and antibiotics/ non-antibiotics)(6 months period)
- Number of episodes with symptoms of illnesses indicating a viral or bacterial infection(6 months period)
- Days of absence from day-care of the child due to infectious episodes and/or symptoms of dysbiosis (diarrhoea) following antibiotic treatment(6 months period)
- Quality of life reported by the parents according to standardized questionnaire(6 months period)
- Number of paediatrician´s consultations due to infectious disease and/ or symptoms of dysbiosis (diarrhoea) following antibiotic treatment(6 months period)
- Hospitalization days due to infectious disease and/or symptoms of dysbiosis(6 months period)
- Number of episodes on antibiotic treatment(6 months period)
- Number of days on antibiotic treatment(6 months period)
- Analysis of stool samples in a subset of children: microbiota changes(6 months period)
- Number of any infectious episodes diagnosed by paediatrician(6 months period)
- Duration of any infectious episode(6 months period)
- Number of days (parents questionnaire and diary) of caretaker´s absenteeism from work due to infectious episodes and/or symptoms of dysbiosis of the child(6 months period)
- Number of episodes of medication use (including prescribed/ non-prescribed medication and antibiotics/ non-antibiotics)(6 months period)
研究者
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