Efficacy and Safety of Specific Oral Tolerance Induction in Children Allergic to Cow's Milk Proteins According to Their Serum Specific IgE Level
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Tolerance to cow's milk
研究概览
简要总结
Induction of oral tolerance in children allergic to cow's milk proteins is not risk-free. The analysis of factors that may influence the outcome is of utmost importance.
The aim of the study is to analyse the efficacy and safety of the induction phase of oral tolerance induction according to specific IgE level, as well as adverse events during the maintenance phase.
Patients allergic to cow's milk are to be included in an oral tolerance induction protocol. Patients will be grouped according to specific IgE levels in serum (ImmunoCAP) into group I (sIgE<3.5 kU/L), II (sIgE 3.5-17 kU/L) and III (>17-50kU/L). Allergic children with similar characteristics will included as a control group. Visits are established at 1, 6 and 12 months after the induction phase. Serum specific IgE levels to cow's milk and its proteins will be determined at inclusion, and at 6 and 12 months visits after the induction phase.
详细描述
Children allergic to cow's milk proteins (CMA) will be included. They have to be diagnosed with CMA during the first year of life and have attended periodic follow-up visits to our Allergy Clinic at Hospital La Paz (Madrid, Spain). Clinical data on personal history of asthma, allergy to other foods and positive reactions upon cow's milk ingestion along with their evolution from initial diagnosis will be recorded.
Prior to inclusion in the SOTI protocol, determination of serum specific IgE to cow's milk (CM), ALA, BLG and casein (ImmunoCAP, Phadia, Uppsala, Sweden) will be performed and current clinical status will be confirmed by oral food challenge (OFC) with cow's milk. An open OFC with CM (3 g of proteins per 100 mL) will be performed following a modified protocol according to the level of allergic sensitisation. Group I will start at a dose of 2 mL, and those in groups II and III started at a dose of 0.005 mL. In both protocols doses will be doubled until objective clinical reactivity is achieved.
Determination of serum specific IgE to cow's milk and its proteins will be performed in the follow-up at 6 and 12 months visits.
In order to evaluate the influence of the level of sensitisation in the result of SOTI, patients will be classified into three groups according to the level of sIgE for CM and/or its proteins: group I (0.35-3.5 kU/L, CAP Class I and II); group II (>3.5-17 kU/L, CAP Class III); group III (>17-50kU/L, CAP Class IV). The highest sIgE level against any of the CM or its proteins will determine the group of inclusion.
A control group of cow's milk allergic children, with similar levels of sIgE, will be included in order to evaluate the natural evolution to tolerance in CMA. They will be followed for one year, after which, clinical reactivity with OFC will be again confirmed. These control patients will selected among those who, after the initial OFC, refuse to undergo SOTI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with cow's milk allergy meeting the following criteria: Immediate-type clinical manifestations, skin (urticaria, angioedema and/or erythema), digestive (acute vomiting and/or diarrhea) or respiratory (bronchospasm and/or rhinitis) involvement in the first two hours after cow's milk ingestion.
- •Skin test readings ≥ 3 mm and specific IgE titers > 0.35 kU/l for whole cow's milk or someone of isolated CMPs (casein, alpha-lactalbumin, beta-lactoglobulin )
- •Age 4 years old or older
- •Specific IgE (measured by ImmunoCAP) lower than 50 KU/L for cow's milk or its proteins
- •Positive oral food challenge with a dose higher than 2 mL
- •Written informed consent signed by parents or legal representatives
排除标准
- •Age younger than 4 y.o.
- •Specific IgE higher than 50 kU/L
- •Patients in whom oral food challenges is contraindicated, because of having a positive accidental reaction with moderate or severe symptoms in the previous 12 months prior to the inclusion.
结局指标
主要结局
Tolerance to cow's milk
时间窗: 12 months
After administration of 250ml of milk, the patient is evaluated to determined if the milk is tolerated or not.
次要结局
- Adverse events(12 months)