Nutrition Sufficiency, Allergy Efficacy and Safety of an Amino Acid-Based Formula Neocate Jr in Children With Food Protein Allergy
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- weight for age
研究概览
简要总结
The main purpose of this study is to evaluate efficacy and safety of an amino acid-based formula Neocate Jr in children with food protein allergy, and to evaluate nutrition sufficiency of Neocate Jr in 1 to 10 years old children with food protein allergy.
详细描述
This is an open, self-controlled multi-center clinical study. Target population is 1～10 years old children allergic to cow's milk and/or food protein, confirmed by pediatrician. The study plans to recruit about 50 subjects to have an intervention period of 4 weeks. Data will be collected at baseline, week 1, 2 and 4. The hypothesis is that the amino acid formula (Neocate Jr) is effective in relieving food protein allergy symptoms, and meanwhile supporting normal growth in children with food protein allergy. Efficacy parameters are the the improvement of food protein allergy symptoms (SCORAD score, serum IgE), growth and development index (weight, height, weight for height), and nutrition related labs (such as hemoglobin, total blood protein, albumin, pre-albumin).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1～10 years old
- •The children with cow's milk/food protein allergy confirmed by pediatrician including sequential feeding/newly diagnosed children, and children with Eosinophilic Esophagitis, Gastroesophageal reflux disease, Food Protein-Induced Enterocolitis Syndrome (clinical symptoms and signs, IgE, oral food challenge, etc.)
- •Stable Vital Signs
- •Written informed consent from the children's parents/guardian
排除标准
- •Allergic to any ingredient in the recipe
- •GI function failure
- •Complete obstruction of the digestive tract
- •Intractable diarrhea
- •Noncooperation of neurologic or mental diseases
- •Disapproval of pediatricians
研究组 & 干预措施
children with food protein allergy
干预措施: Amino acid formula (Neocate Jr) (Dietary Supplement)
结局指标
主要结局
weight for age
时间窗: Change from baseline body weight to Neocate Jr feeding at day 28
Body weight for age is selected as the primary indicator of nutrition sufficiency, and will be measured by the investigator at each visit, and compared to World Health Organization (WHO) standard.
SCORAD score
时间窗: Change from baseline SCORAD score to Neocate Jr feeding at day 28
SCORing Atopic Dermatitis (SCORAD) evaluation scale is selected as the indicator of allergy symptoms improvement, and will be evaluated by the investigator at each visit. The SCORAD score range is between 0 and 103, and lower scores mean a better outcome.
serum IgE
时间窗: Change from baseline serum IgE to Neocate Jr feeding at day 28
Serum IgE is selected as an indicator of allergy improvement, and will be measured by the investigator at baseline and day 28 for comparison.
次要结局
- weight for height(Change from baseline to Neocate Jr feeding at day 28)
- hemoglobin, total blood protein, albumin, pre-albumin(Change from baseline to Neocate Jr feeding at day 28)