NCT06633250招募中不适用
Effect of a Hydrolyzed Rice Protein-based Formula on Growth, Tolerance, and Health-related Quality of Life in Infants With Cow's Milk Protein Allergy: a Randomized Nutritional Clinical Study
Société des Produits Nestlé (SPN)19 个研究点 分布在 3 个国家目标入组 104 人开始时间: 2024年10月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 19
- 主要终点
- Weight-for-age z-score at 4 months post-enrollment
研究概览
简要总结
The main purpose of this study is to demonstrate that the growth of infants fed with the Test Formula is non-inferior those fed with the Control Formula. The study will also evaluate the gastrointestinal tolerance, quatliy of life and acceptability of the new rice protein-based formula in infants with cow's milk protein allergy (CMPA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 8 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent has been obtained from at least one parent (or legally acceptable representative [LAR]), if applicable)
- •Infant gestational age ≥ 37 completed weeks
- •Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg
- •Singleton birth
- •Infant age ≤ 8 months
- •Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk
- •Suspected CMPA as per standard clinical practice and in conjunction with at least 2 symptoms present from the list shown below:
- •Inconsolable crying, regurgitation, liquid stools or constipation, skin atopic lesion, cow's milk provoked temporary urticaria/angioedema or vomiting, bloody streaks in stool, or respiratory symptoms
- •For diagnosis based on either a positive IgE blood test, skin prick test or food challenge, only at least 1 symptom from above list needs to be present
- •Infant is receiving a strict cow's milk elimination diet and will continue receiving this diet until the completion of the study
- •Infant's parent(s)/LAR is of legal age of majority, must have parental authority, must understand the informed consent form and other study documents, and is willing and able to fulfill the requirements of the study protocol
排除标准
- •History of intolerance to eHF formula
- •Any chronic medical diseases (except atopic eczema), chromosomal or major congenital anomalies (based on medical history and/or commonly performed diagnostic criteria)
- •Major gastrointestinal disease / abnormalities (other than CMPA)
- •Known or suspected lactose intolerance or malabsorption
- •Known or suspected soy allergy
- •Glucose-galactose malabsorption
- •Rice protein allergy or intolerance (e.g., rice protein-induced enterocolitis syndrome).
- •Immunodeficiency
- •Persistent wheeze or chronic respiratory disease
- •Severe uncontrolled eczema
- •History of severe anaphylactic reaction (e.g., requiring ≥ 2 doses of epinephrine) to cow's milk or breast milk at any time prior to enrollment
- •Weight-for-age value < -2 or > 2 standard deviations from the WHO Child Growth Standards median at enrollment
- •Height-for-age < -2 or > 2 standard deviations from the WHO Child Growth Standards median at enrollment
- •Infant's parent has other medical or psychiatric condition that, in the judgement of the investigator, would make the infant inappropriate for entry into the study
- •Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment
结局指标
主要结局
Weight-for-age z-score at 4 months post-enrollment
时间窗: From enrollment to 4 months post-enrollment
Weight measured in g and expressed in z scores according to the World Health Organization (WHO) Child Growth Standards.
次要结局
- Stool frequency and consistency(2 months and 4 months post-enrollment)
- Weight(Monthly from enrollment to 4 months post-enrollment)
- Length(Monthly from enrollment to 4 months post-enrollment)
- Head circumference(At enrollmentn and 4 months post-enrollment)
- Tibia lenght(At enrollmentn and 4 months post-enrollment)
- Femur lenght(At enrollmentn and 4 months post-enrollment)
- Gastrointestinal Symptoms(First 7 days post enrollment)
- Cow's Milk-related Allergy Symptom(Monthly from enrollment to 4 months post-enrollment)
- Food Allergy Quality of Life(At enrollment and 4 months post-enrollment)
- Parental self-efficacy in managing food allergy(At enrollment and 4 months post-enrollment)
- Parent-reported infant health-related quality of life(At enrollment and 4 months post-enrollment)
- Complementary food intake(At enrollment, 2 months post-enrollment and 4 months post-enrollment)
- Formula compliance(Monthly from enrollment to 4 months post-enrollment)
- Formula liking(4 months post-enrollment)
- Weight(Monthly from enrollment to 4 months post-enrollment)
- Length(Monthly from enrollment to 4 months post-enrollment)
- Tibia lenght(At enrollmentn and 4 months post-enrollment)
- Head circumference(At enrollmentn and 4 months post-enrollment)
- Femur lenght(At enrollmentn and 4 months post-enrollment)
- Gastrointestinal Symptoms(First 7 days post enrollment)
- Stool frequency and consistency(2 months and 4 months post-enrollment)
- Cow's Milk-related Allergy Symptom(Monthly from enrollment to 4 months post-enrollment)
- Food Allergy Quality of Life(At enrollment and 4 months post-enrollment)
- Parental self-efficacy in managing food allergy(At enrollment and 4 months post-enrollment)
- Parent-reported infant health-related quality of life(At enrollment and 4 months post-enrollment)
- Complementary food intake(At enrollment, 2 months post-enrollment and 4 months post-enrollment)
- Formula compliance(Monthly from enrollment to 4 months post-enrollment)
- Formula liking(4 months post-enrollment)
- Safety - Occurence of AE(From enrollment to 4 months post-enrollment)
研究者
研究点 (19)
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