Oral Immunotherapy for Children With Cow's Milk Allergy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 5
- 主要终点
- Tolerance to cow's milk (4000 mg)
研究概览
简要总结
This clinical trial aims to investigate if oral immunotherapy can help children with cow's milk allergy tolerate cow's milk.
Children aged 6-18 months can take part in the trial.
Main question: What percentage of children can tolerate cow's milk after oral immunotherapy, compared with children who avoid cow's milk?
Children are assigned to these two groups by chance.
Children receiving oral immunotherapy will:
- Take a small, increasing amount of cow's milk daily for 1-1.5 years
- Attend clinic or online visits each time the dose is increased
- Record missed doses
All children will:
- Provide blood samples to measure allergy-related markers
- Undergo an oral food challenge with cow's milk after 1-1.5 years to assess how much they can tolerate
- Report allergic reactions (parent-reported)
- Complete questionnaires (parent-reported)
- Participate in an end-of-study telephone interview with an allergy nurse (parent-reported)
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
- None
入排标准
- 年龄范围
- 6 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 6 to 18 months
- •Cow's milk allergy confirmed at an oral food challenge
- •Reaction threshold below 300 mg of cow's milk protein at the oral food challenge
- •Specific IgE to cow's milk > 0.35 kU/L
- •High risk of persistent allergy to cow's milk (based on defined criteria)
- •Family motivated for oral immunotherapy following shared decision-making using a decision aid
排除标准
- •Uncontrolled asthma, eczema, rhino-conjunctivitis, urticaria, or eosinophilic esophagitis
- •Treatment with biologic or immunosuppressive medication
- •Non-Danish-speaking families
- •Anticipated non-adherent families
研究组 & 干预措施
Oral immunotherapy
Children randomized to oral immunotherapy will ingest a daily dose of cow's milk. Dose escalation will be performed approximately every two weeks at the allergy clinic or via online consultations. After approximately 6 months, a maintenance dose of 300 mg food protein will be reached and continued daily for 6-12 months.
干预措施: Oral immunotherapy with cow's milk (Other)
Avoidance
Children randomized to avoidance will receive standard care for cow's milk allergy, including avoidance of cow's milk.
结局指标
主要结局
Tolerance to cow's milk (4000 mg)
时间窗: 1-1.5 years after enrollment
Proportion of children who tolerate a cumulative dose of 4343 mg of cow's milk protein at an oral food challenge
次要结局
- Parental food allergy related quality of life(At enrollment, 1-1.5 years, and 2-2.5 years (end of study) after enrollment)
- Parental food allergy related anxiety(At enrollment, 1-1.5 years, and 2-2.5 years (end of study) after enrollment)
- Biomarkers(At enrollment, 1-1.5 years, and 2-2.5 years (end of study) after enrollment)
- Study dropout(1-1.5 years and 2-2.5 years (end of study) after enrollment)
- Regular cow's milk intake(2-2.5 years (end of study) after enrollment)
- Missed oral immunotherapy doses(During up-dosing and maintenance phase)
- Is oral immunotherapy worth it(After oral immunotherapy and at 2-2.5 years (end of study) after enrollment)
- Decision aid(Right after decision to start oral immunotherapy)
- Early tolerance to cow's milk (4000 mg)(1 year after enrollment)
- Tolerance to cow's milk (1000 mg)(1-1.5 years after enrollment)
- Allergic reactions(1-1.5 years and 2-2.5 years (end of study) after enrollment)
- Use of adrenaline auto-injector(1-1.5 years and 2-2.5 years (end of study) after enrollment)
研究者
Laura Ozer Kettner
Doctor
Aarhus University Hospital