ORAL IMMUNOTHERAPY FOR COW'S MILK ALLERGY

牛奶过敏的口服免疫疗法

• 批准号: 7604688
• 负责人: ROBERT A WOOD
• 金额: $ 0.17万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604688
• 关键词: Adverse effects; Adverse event; Affect; Age; Allergic; Allergy Shot; Blood; Cattle; Child; Computer Retrieval of Information on Scientific Projects Database; Daily; Diet; Dose; Double-Blind Method; Enrollment; Food; Food Hypersensitivity; Funding; General Population; Grant; Hypersensitivity; Hypersensitivity skin testing; IgE; IgG4; Immunotherapy; Incidence; Individual; Infant; Institution; Intake; Maintenance; Milk; Milk Hypersensitivity; Milk Proteins; Multi-Institutional Clinical Trial; Numbers; Oral; Outcome; Patients; Placebo Control; Placebos; Population; Prospective Studies; Protocols documentation; Pulmonary function tests; Rate; Reaction; Recording of previous events; Recruitment Activity; Research; Research Personnel; Resources; Risk; School-Age Population; Screening procedure; Serious Adverse Event; Site; Skin; Source; Symptoms; Testing; Time; United States National Institutes of Health; Universities; Week; Work; aged; desensitization; design; environmental allergy; outcome forecast; prospective; subcutaneous

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. BACKGROUND: Cow's milk allergy (CMA) is the most common food allergy in infants and young children, affecting 2-3% of the general population. The current management of milk allergy is to avoid all forms of milk until the body naturally develops tolerance. Although previous prospective studies show a good prognosis, with up to 85% of children outgrowing their allergy by age 3, we see an increasing number of children whose CMA persists into school age and beyond. For these children, an alternative to milk avoidance, which carries it's own risks, would be ideal. RATIONALE: Subcutaneous immunotherapy ("allergy shots") has a long record of use for treatment of environmental allergies. It appears that this type of immunotherapy for foods has an unacceptably high rate of side effects. Initial studies using orally administered immunotherapy for food allergies appears safer and potentially effective. STUDY QUESTION: Can oral immunotherapy for milk allergy be safe and effective in reducing or eliminating sensitivity to cow's milk protein in milk-allergic individuals? DESIGN: This is a prospective, multi-center, clinical trial involving children aged 6 to 21 years with persistent cow's milk allergy. These children will be recruited at 2 sites (Johns Hopkins and Duke University) and will undergo initial screening and double-blind, placebo-controlled, food challenge (DBPCFC) to confirm threshold dose for reactivity to milk. Patients will be treated with milk oral immunotherapy (OIT) or placebo for 22-30 weeks. Those who reach an adequate maintenance dose for OIT will undergo a second DBPCFC. Those who develop desensitization will continue with daily milk intake and undergo a third DBPCFC. Those in the treatment group who are not desensitized will return to strict avoidance. Those in placebo group will be offered to begin treatment or continue with strict milk avoidance. Symptom and diet information will be collected initially and at regular intervals. Blood-work, skin prick tests (SPTs), and pulmonary function tests (PFTs), will be done initially and at periodic intervals. STUDY POPULATION: Children between the ages of 6 and 21 years with a history of symptomatic allergy to milk and a positive blood or skin test to milk will be considered for enrollment. OUTCOME MEASURES: Primary: The percentage of patients who can tolerate four times the initial OFC threshold dose or the maximum OFC dose of 8 grams after therapy. Secondary: o Incidence of protocol-defined severe hypersensitivity reactions during the study o Incidence of all serious adverse events during the study o Incidence of all adverse events o To assess for any changes in milk-IgE, m-IgG4, and total IgE during OIT and as milk allergy persists or resolves.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 背景：牛奶过敏（CMA）是婴幼儿中最常见的食物过敏，影响2-3%的普通人群。 目前对牛奶过敏的管理是避免所有形式的牛奶，直到身体自然产生耐受性。 虽然以前的前瞻性研究显示预后良好，高达85%的儿童在3岁时就已经超过了过敏，但我们看到越来越多的儿童的CMA持续到学龄及以后。 对于这些孩子来说，避免喝牛奶的替代品是理想的，因为牛奶本身就有风险。 依据：皮下免疫疗法（“过敏注射”）用于治疗环境过敏有很长的记录。 这种食物免疫疗法似乎具有不可接受的高副作用率。 使用口服免疫疗法治疗食物过敏的初步研究似乎更安全且可能有效。 研究问题：牛奶过敏的口服免疫疗法是否能安全有效地降低或消除牛奶过敏个体对牛奶蛋白的敏感性？ 设计：这是一项前瞻性、多中心、临床试验，涉及6 ~ 21岁持续性牛奶过敏的儿童。 这些儿童将在2个研究中心（约翰霍普金斯大学和杜克大学）招募，并将接受初始筛选和双盲、安慰剂对照、食物激发（DBPCFC），以确认对牛奶反应的阈值剂量。 患者将接受牛奶口服免疫疗法（OIT）或安慰剂治疗22-30周。 达到足够OIT维持剂量的患者将接受第二次DBPCFC。 那些发生脱敏的人将继续每天摄入牛奶，并进行第三次DBPCFC。 治疗组中那些没有脱敏的人会回到严格的回避。 安慰剂组的受试者将被提供开始治疗或继续严格避免牛奶。 最初和定期收集症状和饮食信息。 最初和定期进行血液检查、皮肤点刺试验（SPT）和肺功能试验（PFT）。 研究人群：年龄在6 - 21岁之间，有牛奶过敏症状史和牛奶血液或皮肤试验阳性的儿童将被考虑入组。 结局指标： 主要：治疗后能够耐受4倍初始OFC阈值剂量或最大OFC剂量8 g的患者百分比。 次要： O 研究期间方案定义的重度超敏反应的发生率 O 研究期间所有严重不良事件的发生率 O 所有不良事件的发生率 O 为了评估母乳中IgE、m-IgG 4和总IgE的变化， OIT和牛奶过敏持续或解决。