A Prospective, Randomised, Double-blind Controlled Study, to Evaluate the Safety/Hypoallergenicity of a New Rice-based Hydrolysate Formula With New Ingredient for Infants and Children With Diagnosed Cow's Milk Allergy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 8
- 主要终点
- Hypoallergenicity
研究概览
简要总结
Cow's Milk Allergy (CMA) affects between 2-3% of young children but its severity varies between regions/countries. While the long-term prognosis for CMA is good, with the majority (80-90%) of children outgrowing their allergy by around 3-5 years. Breast feeding is the most optimal form of feeding for all infants, regardless of their condition, and in those with CMA maternal dairy exclusion is recommended as first line treatment. In non-breast fed or mixed feeding, a hypoallergenic milk substitute is recommended for young infants. The AAP and other societies such as EAACI and ESPGHAN considers a formula to be 'hypoallergenic' if at least 90% of children with documented CMA tolerate it, with a 95% CI, under double-blind, placebo-controlled conditions.This equates to at least 29 children who should tolerate the product following blind and open challenge.
详细描述
A prospective, multi-centre double blind randomised placebo-controlled study to demonstrate the safety and tolerance of a new rice-based hydrolysate in children with diagnosed Cow's Milk Allergy (CMA). The test product being a new milk substitute hydrolysed rice-based formula with new ingredient. The results will satisfy the safety requirement when tolerated by 90% of children with proven CMA, with a confidence of 95%. New, and previously diagnosed children with confirmed CMA who meet the inclusion criteria will be eligible to participate in the study. Those included in the intervention phase will have IgE testing and an oral food challenge (OFC) to test and placebo products, in a randomised double-blind design. Children with a negative reaction to both test and placebo products will receive the test product for a period of 7 days (open challenge).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children <10 yrs of age
- •Proven IgE-mediated CMA
- •>2500g at birth
- •> 37 weeks gestation
- •Written informed consent provided by parent(s)/guardian
排除标准
- •Infants/children with severe concurrent illness (other than food allergy/CMA)
- •Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements.
- •Participation in other studies involving use of milk replacement products designed to treat/manage CMA within two weeks prior to entry into this study
- •Current participation in OIT to Cow's Milk
- •Diagnosis of anaphylaxis to Cow's Milk
- •Diagnosis of rice allergy
结局指标
主要结局
Hypoallergenicity
时间窗: 7 days open challenge
90% of children tolerate the TEST formula with a 95% CI - using the double blind placebo controlled food challenge and open challenge (Test vs. placebo).
次要结局
未报告次要终点