NCT03557671已完成不适用
Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins (TRHF 2017) in Children With Confirmed Immunoglobulin E (IgE) or Non-immunoglobulin E-mediated Cow's Milk Allergy (CMA)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 5
- 主要终点
- hypoallergenicity
研究概览
简要总结
The aim of this study is to show the hypoallergenicity of a new thickened rice based formula (TRHF) through a double blind placebo controlled food challenge (DBPCFC), as recommended by the American Academy of Pediatrics, in subjects with IgE-mediated CMA and in subjects with non-IgE-mediated CMA.
详细描述
The study is made of 2 different steps : 1st step is a double blind randomised food challenge where the new formula is compared to a placebo.
The second part of the trial consists in an open phase during which all infants will be fed with the study formula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •with suspected CMA or with a CMA diagnosed by a DBPCFC performed in the last 2 months prior to inclusion
- •free of clinical allergic symptoms for at least one week (i.e. successfully fed an elimination diet);
- •whose parents signed the informed consent
排除标准
- •mainly breast fed, drinking less than 250ml of formula/day, presenting any situation, which, according to the investigator, may interfere with the study participation or lead to a particular risk for the subject
结局指标
主要结局
hypoallergenicity
时间窗: 7 days
the percentage of children tolerating the formula during the double blind placebo controlled food challenge (TRHF 2017 vs. placebo formula).
次要结局
- Regurgitations(1, 2, 3, 4, 5 and 6 months)
- Vomiting(1, 2, 3, 4, 5 and 6 months)
- Bloating and gas(1, 2, 3, 4, 5 and 6 months)
- Sleeping time over 24h satisfaction(1, 2, 3, 4, 5 and 6 months)
- Unexplained crying(1, 2, 3, 4, 5 and 6 months)
- Height(1, 2, 3, 4, 5 and 6 months)
- BMI(1, 2, 3, 4, 5 and 6 months)
- Stool consistency(1, 2, 3, 4, 5 and 6 months)
- Stool frequency(1, 2, 3, 4, 5 and 6 months)
- Respiratory symptoms(1, 2, 3, 4, 5 and 6 months)
- Urticaria(1, 2, 3, 4, 5 and 6 months)
- Angioedema(1, 2, 3, 4, 5 and 6 months)
- Abdominal pain(1, 2, 3, 4, 5 and 6 months)
- Weight(1, 2, 3, 4, 5 and 6 months)
- Blood in stools(1, 2, 3, 4, 5 and 6 months)
- Head circumference(1, 2, 3, 4, 5 and 6 months)
- Eczema(1, 2, 3, 4, 5 and 6 months)
- Number of patients with treatment emergent Adverse Events(1, 2, 3, 4, 5 and 6 months)
研究者
研究点 (5)
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