Post-failure Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Cow's Milk Allergy Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- Number of participants that acquire tolerance for cow's milk after initially failing a cow's milk provocation test
研究概览
简要总结
Subjects who failed to become tolerant within 12 months after randomization within one of the three arms in the TEHITI study, can participate in the post-TEHITI observational trial to study the natural tolerance induction process.
详细描述
In this observational study the investigators will study the time to complete tolerance in cow's milk allergic children who tolerate 20' heated milk but failed the OFC with unheated milk 12 months after passing the 20' boiled cow's milk OFC. Moreoever, the investigators want to document all clinical reactions and potential cofactors during the tolerance induction process. The investigators anticipate that the whole cohort will become tolerant in a time span shorter than 48 months. Therefore the study period in each participant will be 48 months or the period to achieve complete tolerance (which comes first).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants eligible for inclusion in this study must meet all of the following criteria:
- •participation in s68299
- •failure to challenge test with unheated cow's milk
- •passed challenge test with unheated cow's milk but with symptoms developing between challenge and termination visit related to cow's milk intake at home
排除标准
- •Participants eligible for this study must not meet any of the following criteria:
- •Subjects not priorly enrolled in s68299
- •Subjects enrolled in s68299 who passed the challenge test and have no complaints upon regular cow's milk consumption at termination visit
- •Subjects who refuse to consent/assent with the study
结局指标
主要结局
Number of participants that acquire tolerance for cow's milk after initially failing a cow's milk provocation test
时间窗: 48 months
The number of participants that spontaneously acquire tolerance for cow's milk after initially failing a cow's milk provocation test will be counted.
次要结局
- Adverse clinical reactions to cow's milk protein intake during observational period(48 months)
研究者
Dominque Bullens
Dominique MA Bullens, MD PhD
Universitaire Ziekenhuizen KU Leuven