Tolerancia a 2 fórmulas de Leche Infantil Altamente Hidrolizadas en Base a proteínas de Arroz y a caseína en niños Con Alergia a Las proteínas de Leche de Vaca
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Lactalis
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Proportion of infants who tolerate either the rice hydrolyzed protein infant formula or a hydrolyzed casein infant formula after 24h consumption.
研究概览
简要总结
The objective of this double blinded randomized study is to assess the tolerance of two extensively protein hydrolyzed infant formulas, one based on rice protein and the other one on casein, at introduction, and after 3 months of consumption, and their efficacy on growth and on the reduction of allergy symptoms through a 3 months consumption period.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 9 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Full term healthy newborns (37-42 Weeks gestation)
- •Weight at birth ≥ 2500 g
- •Aged between birth to 9 months
- •Symptoms of allergy (Skin or digetive)
- •Suspicion of cow milk protein allergy
- •Infants whose parents/caregivers/legal guardians have the ability to understand and comply with the requirements of the study
- •Infants whose parents/caregivers/legal guardians gave their written informed consent to the infant's participation in the study
排除标准
- •Children who have returned to breastfeeding
- •Presence of any condition, that, in the opinion of the investigator is a contra-indication to the particpation of the infant in the study
- •In the past 15 days, treatment or medication likely to :
- •induce confusion in the allergy tets (ex. : Skin Prick Test) and / or
- •mask the symptoms of an allergic reaction (Anti-allergy medications ; anti-histaminic, anti-leucotrienes, corticosteroids, ...)
- •Newbonrs presenting a chronic or a genetic malformation, or a chromosomal or other disease, that in the opinion of the investigator could mask the study results
- •Children who show signs of malnutrition, or prolonged diarrhea
- •Children whose parents show no willingness to comply with study requirements
- •Consumption of soya protein based, hydrolyzed protein or elemental (amino acid) formula for more than 21 days before inclusion, unless the skin prick test to cow's milk protein is positive, and the IgE level indicates the existence of IgE mediated allergy to cow's milk protein.
研究组 & 干预措施
Picot riz/Celia rice/Sanutri arroz
Picot riz/Celia rice/Sanutri arroz Extensively Hydrolyzed (EH) rice protein infant formula
干预措施: Picot riz/Celia rice/Sanutri arroz (Other)
Damira/Celia peptide hydrolyzed casein
Extensively Hydrolyzed (EH)casein infant formula
干预措施: Damira/Celia peptide hydrolyzed casein (Other)
结局指标
主要结局
Proportion of infants who tolerate either the rice hydrolyzed protein infant formula or a hydrolyzed casein infant formula after 24h consumption.
时间窗: 24h
Tolerance is absence of clinical signs.
次要结局
- Effectivness of the hydrolyzed protein formulas in terms of growth and allergy symptoms improvement.(3 months)