Randomized, Double-blind, Placebo Controlled Food Challenge for the Assessment of Non-allergenicity of Refined Barley Starch in Cereal Allergic Patients
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Challenge outcome according to PRACTALL -score
研究概览
简要总结
Aim of the present study is to verify in a double-blind placebo controlled food challenge (DBPCFC) test that highly purified barley starch ingredient do not cause allergic reaction in subjects most potential to get allergic reaction due to ingredient. Hypothesis is that none of the cereal (mostly primarily wheat) allergic subject recruited to the study will obtain allergic reaction neither to placebo nor to the test ingredient. Scoring of symptoms during the challenges will be based on PRACTALL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age = 1-20 years
- •Diagnosed or suspected cereal allergy (at least to one of the following cereals wheat, barley or rye)
- •Response to cereal proteins confirmed within 2 months in an oral food challenge (OFC)* OR response to cereal proteins confirmed in an OFC more than 2 months ago but clinically verifiable and documented ongoing cereal allergy at the time of inclusion OR diagnosis confirmed in an OFC with wheat performed as part of the study procedures.
- •Voluntarily signed informed consent (including willingness to refrain from cereal containing foods for 1 week before intervention period and be exposed to cereal proteins in the test for eligibility)
排除标准
- •Complex food allergy which make elimination diet impossible to accomplish
- •Patients experiencing unstable or exacerbated atopic disease, such as asthma, atopic dermatitis (AD), urticaria, or allergic rhinitis.
- •Diseases and conditions that might affect safety. Patients should not be challenged if they have chronic medical the event of anaphylaxis/treatment of anaphylaxis. Examples of such conditions include unstable angina pectoris, cardiac disease or dysrhythmias, severe chronic lung disease.
- •Pregnancy should be ruled out by testing or based on history (e.g, before menarche) as appropriate
- •Use of oral corticosteroids. Inhaled and topical steroids or anti-inflammatory medications, such as calcineurin inhibitors or leukotriene antagonists and b-agonists, used at the lowest doses possible and on an established schedule by using fixed doses of medication to maintain a low and stable baseline of atopic disease. Latter medication can usually be continued because their use is unlikely to significantly influence challenge outcomes and their withdrawal might result in exacerbations, affecting disease management and challenge interpretation.
- •Use of antihistamines during the last 4 days before DBPC challenge or period of 5 half-lives of specific agent.
- •Prolonged high dose steroids, omalizumab, or possibly other new drugs to control atopic disease upon decision of investigator.
- •Aspirin/nonsteroidal anti-inflammatory drugs, angiotensin converting enzyme inhibitors, alcohol, antacids and β-blockers upon the decision of the investigator
- •Any chronic condition or its medication that affect immune system
研究组 & 干预措施
Active
Highly purified barley starch packed in sachets; Increasing doses given at clinic as follows: 0.6 g, 2 g, 6 g and 18 g. If required, continued at home with 2 x 18 g daily for 5 days.
干预措施: Barley starch (Other)
Placebo
Maize starch packed in sachets; Increasing doses given at clinic as follows: 0.6 g, 2 g, 6 g and 18 g. If required, continued at home with 2 x 18 g daily for 5 days.
干预措施: Maize starch (Other)
结局指标
主要结局
Challenge outcome according to PRACTALL -score
时间窗: 12-24 days (including 2 blinded challenges)
Allergic reaction to active or placebo. Scoring and decision making based on PRACTALL as defined by Sampson et al., J Allergy Clin Immunol. 2012 Dec;130(6):1260-74.
次要结局
- Severity of atopic dermatitis according to SCORAD-index(12-24 days (including 2 blinded challenges))
- Symptom diary(12-24 days (including 2 blinded challenges))