NCT05618704已完成不适用
A Single Arm, Open Label Intervention Study of a Hydrolyzed Protein Formula to Evaluate Growth, Safety and Tolerance in Infants With a Clinical Diagnosis of Cow's Milk Allergy
Nutricia Research1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2023年3月16日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Adequate growth
研究概览
简要总结
This is a single arm, open label, multicenter intervention trial to evaluate growth parameters, cow's milk related symptoms, gastrointestinal tolerance and safety in infants with cow's milk allergy receiving a hydrolyzed protein formula.
详细描述
The main purpose of this study is to demonstrate adequate growth over a 16-week intervention period in cow's milk allergic infants receiving a hydrolyzed protein formula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 8 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants <8 months of age.
- •Infants with a clinical diagnosis of Cow's Milk Allergy (CMA) per local hospital practice, including any of the following criteria:
- •Based on clinical examination with a careful history, parent-reported symptoms suggestive of CMA, and disappearance of the symptoms when cow's milk was eliminated from the diet for at least two weeks prior to study entry
- •Based on clinical examination with a careful history, parent-reported symptoms suggestive of CMA, and disappearance of the symptoms while being breastfed with maternal cow's milk protein elimination diet for at least two weeks prior to study entry
- •History of CoMiSS® score >10 indicating symptoms are likely cow's milk allergic prior to study entry
- •History of positive result of an oral food challenge with cow's milk prior to study entry
- •Presence of specific Immunoglobulin E (IgE) to cow's milk protein based on skin prick test (wheel size ≥3mm) or radio-allergosorbent-test (RAST) (>0.7 kilounit per liter (kU/L)) prior to or on the day of study entry.
- •3. Infants that are still on dairy-derived extensively hydrolysed formula, amino acid-based formula, hydrolysed rice protein formula, soy-based formula or being breastfed by mothers who are on cow's milk protein elimination diet at study entry.
- •Parents / guardians confirm their intention not to administer any products containing cow's milk protein during the study.
- •Expected to consume the specified age-dependent minimum amount of study product per day during the study.
- •Expected to require a milk substitute for CMA management for at least 16 weeks.
- •Written informed consent provided by parents / guardians, according to local law.
排除标准
- •Birth weight-for-age z-score <-2 Standard Deviation (SD) or >+2SD.
- •Infants <37 weeks gestation requiring specific premature formula at the time of study entry.
- •Infants with severe concurrent illness and/or have undergone gastrointestinal surgery such as bowel resection or stoma placement and/or with Down syndrome or other syndromes where functional gastrointestinal disorders are common.
- •Infants that are more suitable to use Amino Acid Formula (AAF) as first-line formula, including but not limited to those with high risk of anaphylaxis (prior history of anaphylaxis and currently not using extensively Hydrolysed Formula (eHF)), faltering growth / failure to thrive, or severe forms of non-IgE-mediated CMA such as eosinophilic oesophagitis, enteropathies, or Food Protein-Induced Enterocolitis Syndrome (FPIES).
- •Infants with diagnosis of rice allergy or known allergy to any of the ingredients in the study product.
- •Investigator's uncertainty about the willingness or ability of the parents / guardians 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.
研究组 & 干预措施
Hydrolyzed protein infant formula
Experimental
All subjects will take the hydrolyzed protein infant formula
干预措施: Hydrolyzed protein infant formula (Dietary Supplement)
结局指标
主要结局
Adequate growth
时间窗: 16 weeks
Proportion of subjects with growth classified as adequate (by interpreting WHO z-scores weight-for-age and weight-for-length)
次要结局
未报告次要终点
研究者
研究点 (1)
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