NCT04910373终止不适用
Determination of Hypoallergenicity of an Extensively Hydrolyzed Infant Formula in Infants and Children With Cow's Milk Allergy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 8
- 主要终点
- Food Challenge Positive Reactions
研究概览
简要总结
This is a multi-center, randomized, double-blind, placebo-controlled food challenge to be conducted in infants or children with confirmed IgE-mediated cow's milk allergy (CMA), followed by a 7-day open feeding of the experimental formula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has a physician diagnosis of IgE-mediated Cow's Milk Allergy (CMA) based on a clinical history of a reaction resulting in characteristic immediate hypersensitivity symptoms within 2 hours of oral exposure or immediate hypersensitivity symptoms according to physician's observation
- •Participant is willing to undergo confirmatory testing or must have had at least one of the following within 6 months of enrollment:
- •Documentation of milk-specific serum IgE >15 kIUA/L or > 5 kIUA/L if younger than 1 year.
- •Documented cow's milk skin prick test mean wheal >10mm
- •Physician-supervised oral food challenge that elicited immediate, objective, allergic symptoms.
- •Participant agrees to stop oral steroid use within 14 days and antihistamine use within 7 days of confirmation of diagnosis and food challenges.
- •Participant had followed a strict cow's milk protein-free diet prior to enrollment.
- •Parent(s) confirm their intention not to administer any products containing cow's milk protein during the study.
- •Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.
排除标准
- •Participant is exclusively breastfed at the time of enrollment.
- •Participant is consuming an amino acid-based formula due to failure on an extensively hydrolyzed formula.
- •Significant chronic medical diseases including major chromosomal or congenital anomalies, gastrointestinal diseases or abnormalities other than CMA, immunodeficiencies, unstable asthma, asthma treated with biologics (omalizumab or other monoclonal antibody), FPIES, eosinophilic esophagitis, and severe uncontrolled eczema.
- •Previous severe anaphylactic reaction to cow's milk within the last two years.
- •An adverse medical history or current condition that is thought by the investigator to have potential for effects on tolerance or the hypoallergenicity test.
- •Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent.
- •Participant is routinely consuming baked milk products.
结局指标
主要结局
Food Challenge Positive Reactions
时间窗: Food Challenge Day 1 to Food Challenge Day 2
Percent of positive food challenge reactions to the experimental formula
次要结局
- Medication Use(Home Feeding Day 1 to Day 7)
- Food Intake(Home Feeding Day 1 to Day 7)
- Experimental Formula Intake(Home Feeding Day 1 to Day 7)
- Gastrointestinal Symptoms(Home Feeding Day 1 to Day 7)
- Food Challenge Positive Reactions(Home Feeding Day 1 to Day 7)
研究者
研究点 (8)
Loading locations...
相似试验
招募中
不适用
Infant Formula in Infants and Children With Cow's Milk AllergyCow's Milk AllergyNCT06456541Abbott Nutrition96
已完成
不适用
Study to Assess Hypoallergenicity of a New Amino-acid Based Infant Formula in Children With Cow's Milk AllergyCow's Milk AllergyNCT02414243Laboratorios Ordesa41
已完成
不适用
Formula for Children With Cow's Milk AllergyMilk AllergyNCT02317952Perrigo Nutritionals90
已完成
不适用
Double Blind Controlled Trial of an Extensively Hydrolyzed Formula With a Probiotic vs. an Extensively Hydrolyzed Formula Without a ProbioticAllergyNCT01181297Mead Johnson Nutrition
已完成
3 期
A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Children With Perennial Allergic RhinitisPerennial Allergic RhinitisNCT01018862Meda Pharmaceuticals489