Infant Food Allergen Oral Immunotherapy (InFO)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Tolerance to 900 mg protein at a food challenge after 2 years
研究概览
简要总结
The aim is to study whether a multiallergen oral immunotherapy (OIT) strategy with slow up-dosing and low treatment dose against food allergy in young children (0.5-3 years) is safe and effective, a method to cure food allergy and to prevent the development of new food allergies.
Clinical randomized controlled (1:1) blinded interventional trial (RCT) with 2 intervention arms (group A and B).
Among 80 children reacting at the multiallergen food challenge, 40 children will be randomized to receive OIT (oral immunotherapy) with multiallergen powder with a final dose of approximately 200 mg protein of each included food (egg, milk, soy, wheat, walnut, peanut, hazelnut, cashew, almond, lentils)(group A) or to receive placebo powder (gluten-free oatmeal) (group B).
A sub-analysis will be performed of the children not reacting to the baseline challenge, who will be randomized to eat a low dose of the multiallergen powder (group C) or placebo powder (gluten-free oatmeal) (group D) and no specific advice.
详细描述
Today, there is no established curative treatment for food allergies, and those affected must avoid the food that triggers symptoms. The most studied method is oral immunotherapy (OIT) which have mainly been carried out on children >4 years of age. The OIT method implies that the allergic individual eats initially very low doses and gradually increasing amounts of the allergen until a maintenance dose is reached. The treatment aims to induce desensitization or tolerance to the allergen.
Intervention: The intervention substance is a powder containing a prespecified amount of 10 allergens (egg, milk, wheat, lentils, soy, walnut, peanut, hazelnut, cashew, almond), which are the most triggering allergens in children. The product is developed in cooperation with Research Institute of Sweden (RISE).
Clinical randomized controlled (1:1) blinded interventional trial (RCT) with 2 interventions arms (group A and B). A sub-analysis will be performed of the children not reacting to the baseline challenge (group C and D).
Group A: Children with food allergy (sensitization and positive baseline challenge), receiving multiallergen powder OIT, slow up-dosing until 3 teaspoons of the multiallergen powder is reached daily. Food challenge will be performed after 1 and 2 years. 2 years treatment.
Group B: Children with food allergy (sensitization and positive baseline challenge), receiving OIT with placebo (gluten-free oatmeal) followed by maintenance, in total 2 years. Food challenge will be performed after 1 and 2 years.
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)
盲法说明
The study is blinded and neither participants nor the study team physicians know who is receiving multiallergen powder or placebo. Only few persons outside the study has this knowledge.
入排标准
- 年龄范围
- 6 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •0.5-3 years old at inclusion with IgE (>0.1 kUA/l) against at least one allergen (wheat, lentils, egg, milk, soy, walnut, hazelnut, peanut, almond, cashew).
- •Written consent for participation in the study for both guardians.
- •80 children (group A and B) also need a positive baseline food challenge.
- •Children with a negative food challenge (group C and D) (number not determined) do not react at the baseline challenge.
排除标准
- •other serious illness
- •previous life-threatening anaphylaxis (intensive care)
- •eosinophilic esophagitis
- •eosinophilic gastrointestinal disease
- •severe chronic gastroesophageal reflux disease
- •unclear recurrent GI complaints
- •low body weight <2SD
- •participation in another intervention study if included in intervention group
- •severe uncontrolled asthma
- •medication with biological drugs or oral steroids.
结局指标
主要结局
Tolerance to 900 mg protein at a food challenge after 2 years
时间窗: 2 years
Tolerance to 900 mg protein, cumulative dose, of each of the 10 included allergens (in the multiallergen powder), evaluated at a food challenge after 2 years in group A and B. Tolerance is defined as no objective sign of an allergic symptom (urticaria, flush, swelling/angioedema, nasal symptoms, eye symptoms, hoarseness, muffled speech, persistent cough, wheezing, stridor, persistent abdominal pain, severe nausea, vomiting, diarrhea, general impact, drop in blood pressure, decreased oxygenation saturation) within 2 hours after the last dose during the food challenge after 2 years of OIT/placebo.
次要结局
- Tolerance to cumulative dose of 900 mg protein at a food challenge after 1 year(1 year)
- Immunological biomarkers(1 and 2 years)
- Oral brush samples(1 and 2 years)
- Intestinal microbiome(1 and 2 years)
- Changes in eczema status in relation to interventions(1 and 2 years)
- Changes in asthma status in relation to interventions(1 and 2 years)
- Changes in quality of life in relation to interventions(1 and 2 years)
研究者
Idun Holmdahl
Pediatrician, Postdoctoral researcher
Karolinska Institutet