Testing Tolerance in Cow Milk Protein Allergy Patients: Milk Ladder or Direct Milk Administration?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Compare the frequency of tolerance to milk between the two groups
研究概览
简要总结
Majority of children outgrow their allergies, however there are two different methods to re-introduce milk products in the infant diet either direct milk intake in escalating doses or milk ladder, starting with baked milk products instead of pure milk.
This study aims to compare rate of tolerance after milk reintroduction among patient with cow milk protein allergy (CMPA) diagnosed by elimination re-challenge test after six months of elimination diet by milk ladder versus direct milk intake.
详细描述
CMPA is an immunological response to one or more milk proteins. CMPA may be IgE mediated or Non-IgE mediated. It is one of the most frequent causes of food allergies in young children with an estimated prevalence between 1.9% and 4.9% in the first year of life.
CMPA has a good prognosis and cow milk is reintroduced in child diet. Natural history of CMPA shows heterogeneity and it is closely related to the clinical phenotype by which it was presented.
The timing and evaluation of developing tolerance is determined by clinical response to milk introduction.
When diagnosis of CMPA is confirmed, fresh pasteurized cow's milk can be used above 12 months of age in oral food challenge procedure, the starting dose should be lower than a dose that can induce a reaction and then increased step wise to 100ml, in children with mild to moderate reactions doses of 1ml, 3ml, 10ml, 30ml, and 100ml may be given at 30 minutes' intervals.
The milk ladder is an evidence-based plan to re-introduce milk products gradually and in stages for infants and children with mild to moderate cow's milk allergy, starting with food that contain only small amount of well-cooked milk and progressing towards uncooked dairy products and fresh milk. It's only started once child has been on a milk free diet for at least 6 months and they are completely well with no active eczema or gastro-intestinal symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 9 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients age between 9 months old till 3 years old.
- •Patients with symptoms that suggest mild to moderate non IgE mediated Cow Milk Allergy
- •Patients on strict elimination diet for at least six months duration
排除标准
- •Patient with:
- •Chronic gastrointestinal disease (malabsorption, irritable bowel syndrome).
- •Multiple food allergy and/or history of anaphylaxis.
- •Ongoing eczema or severe gastrointestinal symptoms.
结局指标
主要结局
Compare the frequency of tolerance to milk between the two groups
时间窗: intervention will be made six months of elimination diet, and follow up of 2 months later
Questionnaire done to assess occurrence of following symptoms Vomiting, Hematemesis, Diarrhea (using BRISTOL scale), Constipation, Eczema, Skin rash, Perianal inflammation, weight loss in kilograms or failure to gain weight in kilograms, (Colic, Straining and marked Abdominal distension), and recurrent respiratory symptoms within two months of following up after milk reintroduction. If any of the previous items is present, then the patient is considered intolerant to milk. All items should be answered by (no) in order to consider the patient tolerant to milk
次要结局
- Recording of overall percentage of milk tolerance after 6 months elimination diet(intervention will be made six months of elimination diet, and follow up of 2 months later)