Oral peanut immunotherapy with a modified dietary starch adjuvant for treatment of peanut allergy in children aged 10-16 years.

Sydney Children's Hospital Network0 个研究点目标入组 65 人开始时间: 2017年6月22日最近更新: 2021年11月15日

适应症

试验速览

暂无简介。

•Children aged 10-16 years with a diagnosis of peanut allergy with a positive skin prick test to a commercially available peanut extract (wheal at least 3mm larger than the negative control) and confirmation of clinical reactivity to roasted peanut in a double blind, placebo-controlled food challenge (DBPCFC) with a cumulative threshold of >9mg but <3000mg of peanut protein; tolerant of soy (DBPCFC is given in a soy-based matrix) at a food challenge; parents, or legal guardians, must give informed consent and the child must also agree to partake in the study.

•Previous admission to intensive care unit for the management of a peanut allergic reaction; clinically significant chronic disease other than eczema, rhinitis or asthma; poorly controlled asthma in the last 3 months (as defined by clinican judgement with reference to the ICON consensus) or asthma requiring oral corticosteroids in the previous 3 months; those in the first year of immunotherapy (subcutaneous or sublingual) for respiratory allergens; those receiving anti-IgE therapy, oral immunosuppressants, beta-blockers or ACE inhibitor therapy; a clinical allergy to soya or sunflower seed; tolerance to roasted peanut in a double blind, placebo-controlled food challenge with thresholds <10mg or 3000mg or more peanut protein; pregnancy; or unwilling or being unable to fulfil study requirements.

发起方

Sydney Children's Hospital Network