Effects of Different Dietary Regimens on Tolerance Acquisition in Children With Cow's Milk Allergy
2012年7月5日 更新者：Roberto Berni Canani、Federico II University
Otherwise healthy infants (1-12 months of age at the diagnosis) with CMA were prospectively evaluated.
Patients with cow's milk protein-induced anaphylaxis, eosinophilic disorders of the gastrointestinal tract, and food protein induced enterocolitic syndrome were excluded.
A food challenge was performed 6 and 12 months after the diagnosis to assess clinical tolerance acquisition.
Main demographic and clinical characteristics were collected for each patient.
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
300
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
1个月 至 1年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
We prospectively evaluated otherwise healthy infants (1-12 months of age at the diagnosis) visit one the Pediatric Gastroenterology and Allergology Centre because of the necessity of a diagnostic oral food challenge for cow's milk proteins.
Children were in stable clinical condition without signs of CMA already on exclusion diet with an hypoallergenic formula for a period of 7-15 days as presented by the general paediatrician, immediately the symptoms appear and before being attended at the Center for diagnosis of CMA.
描述
Inclusion Criteria:
- Otherwise healthy infants (1-12 months of age at the diagnosis) with cow's milk allergy were prospectively evaluated
Exclusion Criteria:
- Patients with cow's milk protein-induced anaphylaxis, eosinophilic disorders of the gastrointestinal tract, and food protein induced enterocolitic syndrome were excluded.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
infants receiving extensively hydrolysed casein formula
infants receiving extensively hydrolysed casein formula as substitutive formula
|
|
extensively hydrolysed casein formula with Lactobacillus GG
infants receiving extensively hydrolysed casein with LGG as substitutive formula
|
|
infants receiving rice hydrolyzed formula
infants receiving rice hydrolyzed formula as substitutive formula
|
|
infants receiving soy-based formula
infants receiving soy-based formula as substitutive formula
|
|
infants receiving amino-acid based formula
infants receiving amino-acid based formula as substitutive formula
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
the effect of different dietotherapeutic approaches on the time of tolerance acquisition in children with cow's milk allergy
大体时间：about 4 year
|
. Otherwise healthy infants (1-12 months of age at the diagnosis) with CMA were prospectively evaluated.
Patients with cow's milk protein-induced anaphylaxis, eosinophilic disorders of the gastrointestinal tract, and food protein induced enterocolitic syndrome were excluded.
A food challenge was performed 6 and 12 months after the diagnosis to assess clinical tolerance acquisition.
Main demographic and clinical characteristics were collected for each patient.
|
about 4 year
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年10月1日
初级完成 (实际的)
2012年4月1日
研究完成 (实际的)
2012年4月1日
研究注册日期
首次提交
2012年7月3日
首先提交符合 QC 标准的
2012年7月5日
首次发布 (估计)
2012年7月6日
研究记录更新
最后更新发布 (估计)
2012年7月6日
上次提交的符合 QC 标准的更新
2012年7月5日
最后验证
2012年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.