Study to Assess Hypoallergenicity of a New Amino-acid Based Infant Formula in Children With Cow's Milk Allergy (RAF)
2020年1月8日 更新者：Laboratorios Ordesa
A Multicenter, Randomized, Controlled, Cross-over Study to Assess Hypoallergenicity of a New Amino-acid Based Infant Formula in Children With Cow's Milk Allergy
This is a prospective, controlled, multi-country study to verifying the hypoallergenicity of the new amino acid-based formula in infants and children aged< 12 years with documented cow's milk protein allergy (CMPA).
研究概览
详细说明
Not Provided
研究类型
介入性
注册 (实际的)
41
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Rome、意大利
- Ospedale Pediatrico Bambino Gesù
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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
不超过 12年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
Children with documented cow's milk allergy, confirmed by one of the following criteria, within six months prior to study start (visit 2):
- Positive double-blind, placebo-controlled oral food challenge (DBPCFC) with cow's milk OR
- Positive open or single-blind oral food challenge with cow's milk carried out under the supervision of a specialist in children with clear immediate reactions and a positive test for specific IgE (in serum [sIgE>0,35 KUI/L] or skin prick test [SPT ≥ 3 mm]) OR
- Reported convincing allergic symptoms following an exposure to milk or a milk-containing food product and detectable serum milk-specific IgE or positive skin prick test
- Aged ≤12 years of age at screening.
- Expected consumption of a minimum of 250ml of study formula per day during the open challenge.
- Written informed consent from one or both parents (depending on the local legislation) or legal representative.
Exclusion Criteria:
- Children who receive breastfeeding at study enrolment.
- Had any chronic medical diseases, chromosomal or major congenital anomalies, or major gastrointestinal disease/abnormalities (other the CMPA); had immunodeficiency; antihistamine [excluding eye drops] use in 7 days prior to a food challenge or oral steroid use within 14 days prior to enrolment; unstable asthma; severe uncontrolled eczema;
- Severe anaphylactic reaction [required ≥ 2 doses of epinephrine] to milk or breast milk within the past 2 years;
- Existing illness that could interfere with formula acceptance or identification of allergic reactions.
- Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
- Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
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
- 主要用途：其他
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：New Amino Acid formula
New Amino-Acid based Infant Formula
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Ordesa's Amino-Acid based Infant Formula
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有源比较器：Control formula
Commercially available Amino Acid Formula
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Commercially available Amino Acid Formula
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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 |
|---|---|---|
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Hypoallergenicity as Assessed by Reaction to Amino-acid Based Infant Formula
大体时间：14 days
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To demonstrate that the test formula does not cause immediate and/or delayed allergic reactions to a double blind placebo control food challenge (DBPCFC) and/or a subsequent open food challenge (OFC).
Incidence of immediate and/or delayed allergic reactions to the DBPCFC with the study product and/or active comparator and/or during the subsequent OPEN challenge phase of the study.
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14 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Cow's Milk Allergy Related Symptoms
大体时间：14 days
|
Cow's Milk Allergy related Symptoms recorded at visit 1 and visit 4 using the Vandenplas symptom-based score (SBS). The scoring ranges from 0 to 33. Each symptom has a maximal score of 6, except respiratory symptoms where the maximal score is 3. If final score ≥ 12, the symptoms are likely cow's milk related. This could potentially be CMPA. If final score <12, the symptoms are less likely related to cow's milk. Look for other causes. |
14 days
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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。
调查人员
- 首席研究员：Claudia Banzato, MD、Azienda Ospedaliera Universitaria Integrata, Verona, Italy
- 首席研究员：Maria Pedrosa, MD、Hospital Universitario La Paz
- 首席研究员：Elena Alonso, MD、Hospital General Universitario Gregorio Marañón, Madrid, Spain
- 首席研究员：Montserrat Bosque, MD、Hospital Universitario Parc Taulí Sabadell, Barcelona, Spain
- 首席研究员：Anna Mª Plaza, MD、Hospital Sant Joan de Déu, Barcelona, Spain
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
2015年4月1日
初级完成 (实际的)
2016年12月30日
研究完成 (实际的)
2016年12月30日
研究注册日期
首次提交
2015年2月11日
首先提交符合 QC 标准的
2015年4月7日
首次发布 (估计)
2015年4月10日
研究记录更新
最后更新发布 (实际的)
2020年1月18日
上次提交的符合 QC 标准的更新
2020年1月8日
最后验证
2020年1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.
New Amino Acid formula的临床试验
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)终止
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Wake Forest University Health SciencesNational Cancer Institute (NCI)完全的
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National Cancer Institute (NCI)Eastern Cooperative Oncology Group; NCIC Clinical Trials Group; Southwest Oncology Group; Cancer...终止IIIA 期非小细胞肺癌 | IIIB 期非小细胞肺癌 | 复发性非小细胞肺癌 | IV 期非小细胞肺癌美国, 加拿大
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Albert Einstein College of MedicineNational Cancer Institute (NCI); Eli Lilly and Company; OSI Pharmaceuticals完全的IIIB 期非小细胞肺癌 | 肺腺癌 | 复发性非小细胞肺癌 | IV 期非小细胞肺癌 | 细支气管肺泡癌 | 大细胞肺癌美国
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Albert Einstein College of MedicineNational Cancer Institute (NCI)完全的
-
National Cancer Institute (NCI)完全的
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University of California, San FranciscoMerck Sharp & Dohme LLC撤销肺非小细胞癌 | II 期肺癌 AJCC v8 | IIA 期肺癌 AJCC v8 | IIB 期肺癌 AJCC v8 | IIIA 期肺癌 AJCC v8 | I 期肺癌 AJCC v8 | IA1 期肺癌 AJCC v8 | IA2 期肺癌 AJCC v8 | IA3 期肺癌 AJCC v8 | IB 期肺癌 AJCC v8美国