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临床试验/NCT01473823
NCT01473823Unknown不适用

Treatment of IgE Associated Eczema With Omega-3 Long Chain Polyunsaturated Fatty Acids in Infancy and the Development of Bronchial Asthma in Childhood

Ostergotland County Council, Sweden1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2012年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
160
试验地点
1
主要终点
Prevalence of bronchial asthma

研究概览

简要总结

Although some causal factors in allergy development such as allergen exposure and environmental pollution have decreased during recent years, the incidence of the allergic diseases has increased in the Western world. Since the genetic predisposition to develop allergies cannot change in such a short time it is conceivable that, instead of the emerging of some new and unknown risk factors, some protective factors seem to have disappeared in the Western world.

Allergic disease is a tendency to develop allergies to allergens in the surrounding environment. The most common symptoms are eczema and food allergy in the early life, bronchial asthma (AB) later in childhood and allergic rhino conjunctivitis (ARC) during school age and adolescence, the so-called allergic march. Some person may develop only one, but others some or all of the symptoms. Inheritance, environment and allergen exposure are important factors affecting this march but there are important factors that predict later development of diseases. Sensitization to egg (positive skin prick test or specific IgE to egg in the serum) combined with skin problems in infancy predispose strongly to the development of allergic asthma in later life.

The purpose of this work is to supply children with early development of IgE associated eczema and food allergy with omega-3 LCPUFA before the age of 12 months and assess the effect of the supplementation on the future development of skin symptoms, food allergy, sensitisation against inhalant allergens and asthma in these children. We will also assess immunological markers of Th2-skewed immunity in relation to clinical effect of the supplementation.

Families with children younger than 12 months referred to the paediatric department at Linköping University Hospital, Motala, Norrköping and Jönköping Hospitals in the South East of Sweden, with the diagnosis IgE associated eczema and sensitised against food allergens (egg, milk, wheat and/or soya) will be invited to participate in this study. Clinical examination by a paediatrician and assessment of disease severity with SCORAD will be performed by a research nurse at inclusion. The children will be assessed every six months by a nurse until 2.5 years of age and by a paediatrician at 3 years of age. Later clinical assessment will be performed yearly until age 7.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
3 Months 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Eczema and sensitisation to food allergens

排除标准

  • Fish allergy within family

结局指标

主要结局

Prevalence of bronchial asthma

时间窗: 7 years

次要结局

  • Severity of allergic symptoms and sensitisations to inhalants(3 years)

研究者

发起方
Ostergotland County Council, Sweden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Karel Duchén, MD

Principal Investigator

Ostergotland County Council, Sweden

研究点 (1)

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