Clinical Trial Evaluating the Effects on Growth, Safety and Tolerance of a Rice Protein Hydrolysate Formula Compared to a Cow's Milk Extensively Hydrolysed Protein Formula in Infants With Cow's Milk Protein Allergy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 117
- 试验地点
- 9
- 主要终点
- Growing change
研究概览
简要总结
This is a multicenter, controlled, randomized, prospective, non-inferiority, double blind intervention trial to evaluate the children growth (at 6, 9 and 12 months) using a rice hydrolysed protein formula compared to an extensively cow's milk protein hydrolysed formula for the management of Cow's Milk Protein Allergy (CMPA).
详细描述
The main purpose of this study is to demonstrate that the rice protein hydrolysed based formula manufactured by Ordesa ensures proper growth and as secondary outcomes, that the formula is devoid of any risk of arsenic or other potential contaminants toxicity and its effect on the duration of CMA (Cow Milk Allergy) from cow's milk protein allergy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 10 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects up to 10 months old with clinical history of a reaction to cow's milk protein and/or confirmed diagnosis (up to grade II anaphylaxis) of allergy to cow's milk protein by one of the following criteria, within two months prior to the baseline visit are eligible to enter the study:
- •Negative or positive skin prick tests ( fresh milk, rice, casein hydrolysates)
- •Negative or positive specific IgE for cow's milk proteins (alphalactalbumine, betalactoglobuline, caseine and cow's milk)
- •Negative or positive Milk Atopy Patch Test
- •Positive Double Blind Placebo Control Food Challenge (DBPCFC) with cow milk
- •Gestational Age 37-42 weeks inclusive
- •Apgar SCORE >7 at 5 minutes
- •Singleton birth
- •Birth weight ≥2.500 g
- •Written informed consent
排除标准
- •Previous signs of allergy to any extensively hydrolysed formula
- •Confirmed history of acute severe, potentially life threatening reaction after isolated accidental ingestion of cow's milk e.g. history of anaphylactic reaction, graded more or equal to grade III, as this could not be compatible with an allocation to the eHF group
- •Daily formula intake < 100 ml
- •Major congenital malformations or neonatal diseases
- •Severe concurrent or chronic diseases
- •Intrauterine growth retardation
- •Neonatal infections ( e.g. CMV, HIV)
- •Simultaneous participation in other clinical trials
- •Parents not signing written informed consent
- •Unable to adhere to protocol requirements or study visits due to non compliance of parents or caregivers.
- •Liver, kidney, haematological abnormalities as judged clinically by investigators at baseline.
研究组 & 干预措施
eHF (Extensive Hydrolysed Formula)
Extensive Hydrolysed Cow's Milk Protein Formula (eHF)
干预措施: eHF (Other)
HRF (Rice formula)
Hydrolyzed Rice Protein Formula (HRF)
干预措施: HRF (Other)
结局指标
主要结局
Growing change
时间窗: 6 months
To evaluate the children growth using a rice hydrolysed protein formula compared to an extensively cow's milk protein hydrolysed formula for the management of CMPA.
次要结局
- Nutritional adequacy(6 months)
- Tolerance acquisition to cow's milk protein measured by a cow milk OFC (Open Food Challenge)(6 months)
- Contaminants(6 months)