A Study of the Efficacy of Milk Oral Immunotherapy in Children
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of Subjects Who Completed Desensitization Protocol
研究概览
简要总结
Background and Rationale
For patients with Immunoglobulin E (IgE)-mediated food allergy, the current management includes identification of the causative food and avoidance. Specifically, among young children, cow's milk allergy is the most common food allergy, occurring in as many as 2-3%. Given the prevalence of milk and the difficulty to avoid it in the diet, the investigators aim to investigate the safety and efficacy of oral immunotherapy for cow's milk allergy.
Main Objective
The primary objective is to study the efficacy of milk oral immunotherapy.
Target Population
Children aged six to 17 years with a history of cow's milk allergy will be recruited from The Children's Hospital of Philadelphia Allergy clinical offices for the investigators study.
详细描述
Primary Study Interventions
Prior to and after the desensitization, we will conduct double-blind placebo controlled food challenges to cow's milk protein. During the desensitization phase, we will give increasing doses of cow's milk protein by mouth on a weekly basis, as tolerated. The desensitization protocol starts with dilutional doses of milk and build up to a goal of 8 ounces of cow's milk.
Main Study Outcome Measure
The percentage of children completing the desensitization protocol in each study group will be the primary outcome measure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be age six to 17 years and have a history of cow's milk allergy. Subjects shall maintain strict avoidance of consumption of all cow's milk protein containing foods.
- •Subjects will have a history (within the past six months) of a positive skin prick test to milk extract or an immunocap IgE level greater than 0.35 kilounits per liter (kU/L), and a positive allergic reaction history to milk within the past 12 months.
- •Subjects must be in good health, as determined by medical history and physical examination performed by a study physician.
- •Females of childbearing potential must be using an effective method of contraception, including abstinence, and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study.
- •Informed consent of parent or legal guardian is required.
排除标准
- •Ability to tolerate eight ounces of cow's milk or eight grams of milk protein powder
- •A history of soy allergy
- •A history of food protein induced enterocolitis syndrome to milk
- •A history of anaphylaxis requiring hospitalization
- •A history of intubation related to asthma and/or a history of an intensive care unit admission for asthma management
- •A current diagnosis of severe persistent asthma [forced expiratory volume in 1 second (FEV1) < 60% of predicted, as defined by National Heart, Lung, and Blood Institute (NHLBI) guidelines, despite current therapy
- •A current diagnosis of severe atopic dermatitis
- •A serious chronic medical condition, including neurologic, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease
- •Use of oral or injection steroids within one month of protocol initial visit
- •An acute illness within one week prior to the first dose of oral immunotherapy
- •Use of antihistamines within seven days prior to double blind placebo controlled food challenge (DBPCFC)
- •Use of chronic immunomodulatory therapy
- •Participation in another experimental therapy study
- •Participation in a study for the treatment of food allergy in the past 12 months
- •Inability to discontinue antihistamines for skin testing and food challenges
研究组 & 干预措施
Delayed Sensitivity
All subjects will undergo a food challenge (week 2). Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder will begin build-up of desensitization during Week 16 and continue thru Week 50. Total active participation will last 51 weeks.
干预措施: Milk Oral Immunotherapy (Dietary Supplement)
Delayed Sensitivity
All subjects will undergo a food challenge (week 2). Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder will begin build-up of desensitization during Week 16 and continue thru Week 50. Total active participation will last 51 weeks.
干预措施: Milk Protein Powder (Drug)
Delayed Sensitivity
All subjects will undergo a food challenge (week 2). Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder will begin build-up of desensitization during Week 16 and continue thru Week 50. Total active participation will last 51 weeks.
干预措施: Food Challenge (Other)
Immediate Sensitivity
All subjects will undergo a food challenge (week 2). Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder will begin build-up of desensitization during Week 3 and continue thru Week 35. Total active participation will last 38 weeks.
干预措施: Milk Oral Immunotherapy (Dietary Supplement)
Immediate Sensitivity
All subjects will undergo a food challenge (week 2). Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder will begin build-up of desensitization during Week 3 and continue thru Week 35. Total active participation will last 38 weeks.
干预措施: Milk Protein Powder (Drug)
Immediate Sensitivity
All subjects will undergo a food challenge (week 2). Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder will begin build-up of desensitization during Week 3 and continue thru Week 35. Total active participation will last 38 weeks.
干预措施: Food Challenge (Other)
结局指标
主要结局
Number of Subjects Who Completed Desensitization Protocol
时间窗: 1 year
Subjects who withdrew prior to completing the desensitization protocol and those who experienced anaphylaxis during the desensitization protocol (i.e., were unable to complete the protocol) were considered to be "treatment failures". Subjects who completed the desensitization protocol were considered to be "treatment successes".
次要结局
未报告次要终点