Allergy Against Different Species of Fish in Children and Adolescents Allergic to Fish
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Allergic response to fish allergens with dosing escalation
研究概览
简要总结
Study hypothesis:
Some children and adolescents with fish allergy can tolerate eating some species of fish
Purpose of the study:
The purpose of this study is to determine to which degree fish allergic children and adolescents can tolerate some species of fish and find the minimal eliciting allergen dose to which only 10% of participants get allergic reaction.
Participants:
Participants are 40 patients recruited from children and adolescents outpatient clinics at the University Hospital of North Norway with a history of fish allergy and sensibilisation of one or more fish species with either positive specific IgE in serum or skin prick test. Patients with sensibilisation to one or more fish species that never have eaten fish are also recruited.
Method:
- All participants undergo a clinical examination including lung function test with spirometry before inclusion in the study.
- All participants are tested for allergic sensibilisation with measure of specific IgE against common food and inhalation allergens in addition to 10 different fish species.
- All participants are challenged with cod, salmon, mackerel and placebo, disguised in a chocolate mousse. The challenges are performed in randomized order with Double Blind Placebo Controlled Food Challenge (DBPCFC) on 4 different challenge days with minimum 6 weeks in between each challenge day.
- Participant with allergy to pollen will not be challenged during pollen season.
- Test food is developed especially to this study in cooperation with The National Institute of Food Research in Norway and The University of Manchester. The National Institute of Food Research in Norway have produced a dried powder of cod, salmon and mackerel. The "Molecular Allergology group at Manchester Institute of Biotechnology, the University of Manchester, have produced test kits based on chocolate mousse containing low and high doses of the fish powders. The National Institute of Food Research have measured protein content and microbiology in the fish powders. The Molecular Allergology group have provided quality measurements of the final product and tested the disguise in a sensoric test panel.
- Participants with no allergic reaction to one or more of the blinded challenges undergo open food challenge with larger doses of cooked fish than used in the DBPCFC, after the randomization has been broken.
详细描述
Introduction:
Fish have an important role in human food providing a valuable source of highly assimilated proteins and consumption of fish is increasing all over the world. Fish allergy is one of the most common food allergies together with milk, egg, nuts, peanuts, fruits, wheat, soy and seafood. It is more common in coastal countries and countries with traditions in fish industry and where fish plays an important role in food traditions. This is the situation in Northern Norway where fishing and fish industry have been the most important way to make a living and fish an important part of the food. Allergy to fish is particularly common in children and young adults. The symptoms related to fish allergy vary from mild symptoms to anaphylaxis. Most patients with fish allergy avoid all species of fish and health care workers often advice them to do so. The major allergen in fish is a muscle parvalbumin resistant to heat, chemical denaturation and proteolytic enzymes. Due to homology in the amino acid sequence in parvalbumins in different fish species, cross-reactivity exists.
However, clinical experience, studies on sensibilisation, and some open food challenge studies indicates that some patients with fish allergy can tolerate some species of fish. The main purpose of this study is to find to which degree fish allergic children and adolescents can tolerate some species of fish, using DBPCFC as the gold standard in diagnosis of food allergy, and thereby avoid unnecessary food restrictions in their diet.
The food industry often label their products with "main contain allergen" because they lack information about threshold doses for allergic reactions. Unnecessary labeling of food results in less variation in the diet for food allergic patients. Another purpose of this study is to find the Minimal Eliciting Dose to which 10% of the participants get allergic reaction, and thereby contribute to a more precise labeling of food.
Method:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known or suspected allergy to fish with either positive specific s-IgE or skin prick test to one or more fish species
- •Either positive specific s-IgE or spin prick test to one or more fish species and never eaten fish.
排除标准
- •Serious chronic disease
结局指标
主要结局
Allergic response to fish allergens with dosing escalation
时间窗: Within two hours after last dosage
Symptoms are recorded on a clinical manifestations record sheet based on a protocol from the University Hospital of South Manchester with grading of the symptoms and defined stop criteria.
次要结局
- Correlation coefficient between specific IgE to fish allergens and allergic response(One day after exposure)