A Follow-up Study to 7 Years of a Randomized, Double-blinded, Placebo-controlled Study on the Influence of Probiotics on Atopy With Focus on Respiratory Allergic Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 253
- 试验地点
- 1
- 主要终点
- Asthma
研究概览
简要总结
The investigators had conducted an initial double-blind, placebo-controlled clinical trial (NCT00318695) to study the effects of probiotic supplementation from birth to 6 months of age in the incidence of atopic diseases at 2 years old. This is then further investigated up to 5 years of age in a follow-up study NCT00365469 to assess the longer term beneficial effects.
This current study intends to follow-up for another 2 years until 7 years of age as this is critical in the evaluation of respiratory allergies in the form of clinical asthma and allergic rhinitis.
详细描述
This study intends to continue the initial double-blind, placebo-controlled randomized clinical trial (NCT00318695) which involved 253 subjects with a first degree family history of allergic disease. The infants received at least 60ml of commercially available cow's milk based infant formula with or without probiotic supplementation (Bifidobacterium longum [BL999] 1×10*7 colony-forming unit (cfu)/g and Lactobacillus rhamnosus [LPR]2×10*7 cfu/g) daily from the first day of life for the first 6 months. A follow-up study (NCT00365469) up to 5 years of age is currently in process.
This current study plans to continue the follow-up for a further 2 years till the cohort reaches 7 years of age. This study will only involve telephone calls which will be conducted every 3 months to ascertain for symptoms and incidence of respiratory allergic disease.This is critical in the evaluation of asthma and allergic rhinitis which tend to develop later in life and this step-wise, temporal development of respiratory allergies has been described as "Atopic March".
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 7 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject has completed the both NCT00318695 and NCT00365469 studies.
- •Parent(s) / Guardian consent to the subject's participation in the study.
- •Subject and the parent(s)/ guardian are willing to comply with the study procedures
排除标准
- •The parent is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained.
- •The parent is unable/ unwilling to comply with study procedures
结局指标
主要结局
Asthma
时间窗: 7 years of age
次要结局
- Allergic Rhinitis(7 years of age)
研究者
Paediatrics
A/Prof Lynette Shek
National University Hospital, Singapore
