NCT06456541招募中不适用
Determination of Hypoallergenicity of an Extensively Hydrolyzed Infant Formula in Infants and Children With Cow's Milk Allergy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 17
- 主要终点
- Food Challenge Reactions
研究概览
简要总结
This is a multi-center, randomized, double-blinded, placebo-controlled food challenge to be conducted in infants and 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's parent(s) is/are willing for their child to undergo confirmatory testing or must have had at least one of the following within 6 months of enrollment:
- •Physician diagnosis of IgE-mediated CMA, according to the participant's clinical history (e.g. gastrointestinal symptoms, hives, respiratory symptoms or angioedema) AND, detectable serum milk-specific IgE >0.7 kUᴀ/L or positive skin prick test wheal ≥5 mm;
- •Documentation of milk-specific serum IgE ≥15 kUᴀ/L or ≥ 5 kUᴀ/L if younger than 1 year;
- •Documented cow's milk skin prick test wheal ≥8mm;
- •Physician-supervised oral food challenge that elicited immediate, objective, allergic symptoms.
- •Participant's parent(s) agree for their child to stop oral steroid use within 14 days and antihistamine use within 7 days prior to confirmation of diagnosis and food challenges.
- •Participant had followed a strict cow's milk protein-free diet for at least 2 weeks prior to enrollment.
- •Parent(s) confirm their intention not to administer any products containing cow's milk protein during the study.
- •Participant is between 3 months and 12 years of age at enrollment.
- •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 partially or 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, eczema and/or food allergies 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 consuming baked milk products.
- •Use of and/or changing dose of high potency steroids.
- •Participant is treated with any oral immunotherapy (sublingual, subcutaneous, and epicutaneous) for any food allergy.
研究组 & 干预措施
Experimental Extensively Hydrolyzed Formula
Experimental
Administered during food challenge and at home feeding period of 7 days
干预措施: Experimental Extensively Hydrolyzed Formula (Other)
Placebo Extensively Hydrolyzed Formula
Placebo Comparator
Administered during food challenge
干预措施: Placebo Extensively Hydrolyzed Formula (Other)
结局指标
主要结局
Food Challenge Reactions
时间窗: Food Challenge 1 to Food Challenge 2 (within 14 days of the Food Challenge 1) (followed by 7 days of feeding the experimental formula at home.)
Percent of positive food challenge reactions to the experimental formula administered to cow's milk allergic infants and children.
次要结局
- Food Intake during Study(Home Feeding Day 1 to Day 7)
- Gastrointestinal Symptoms(Home Feeding Day 1 to Day 7)
- Medication Use(Home Feeding Day 1 to Day 7)
- Volume of Experimental Formula Intake(Home Feeding Day 1 to Day 7)
- Food Challenge Positive Reactions(Home Feeding Day 1 to Day 7)
研究者
研究点 (17)
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