Low Dose Multi Allergen Oral Immunotherapy for Food Allergy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Desensitization to allergic food as assessed by change in maximum tolerated dose in a dichotomous manner
研究概览
简要总结
Oral immunotherapy (OIT) is a food allergy treatment where small amounts of the food a child is allergic to is eaten and gradually increased over time with the aim to be able to eat a certain amount of the allergen without experiencing an allergic reaction. While this process works in many children there are concerns about safety, feasibility and drop-outs and how to adapt protocols for multiple allergies.
Many OIT trials have targeted approximately 4000mg of single food/day. In these trials up to 40% drop-out. There is evidence much lower doses can have beneficial effects.
The investigators will evaluate if low doses of foods can allow for OIT to multiple foods. This approach may have efficacy against accidental exposure and be able to demonstrate immune changes. This approach may have a low burden of treatment and a low rate of allergic reactions and
详细描述
This is a single-arm, open label, study of the intervention of low dose multiple-nut OIT in nut allergic children.
After meeting eligibility criteria, participants will have a food challenge to 2-5 nuts.
If the oral food challenge is positive, participants will be enrolled in the study to multiple nut OIT. A blood draw and quality of life (QOL) survey will occur at baseline.
Participants will have dose escalation visits of the multiple nut OIT every 2 months to a target dose of 30mg of each nut protein. A blood draw and QOL survey will occur at 6 months.
Participants will then continue with daily ingestion of the 30mg of each nut protein for 1 year with visits every 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relevant allergy to 2-5 nuts
- •Serum immunoglobulin E (IgE) >0.35 kilounits/L (kU/L) (determined by UniCAP within the past 12 months) and/or a SPT to nut >3 mm compared to control
- •Positive oral food challenge (OFC) to less than 300mg of a nut in the nut mix at baseline (cumulative 444mg).
排除标准
- •History of frequent or repeated, severe or life-threatening episodes of anaphylactic shock
- •use of omalizumab or other non-traditional forms of allergen immunomodulatory therapy (not including corticosteroids) or biologic therapy in the 12 months prior to study entry
- •history of eosinophilic gastrointestinal disease, uncontrolled asthma as defined by Global Initiative for Asthma (GINA)
- •use of beta-blockers(oral)
- •use of angiotensin-converting enzyme inhibitors (ACE)
- •fails to tolerate 4mg of peanut after the first desensitization day
- •Other significant medical conditions that in the opinion of the investigator prevent participation in the study,
- •Previous intubation due to allergies or asthma,
- •Symptomatic atopic dermatitis or chronic urticaria which may interfere with ability to evaluate oral immunotherapy and /or requiring daily medication including antihistamines,
- •Patients with problems related to compliance or following study instructions, Inability to come to hospital every for dose escalation
- •Pregnancy
- •Non-fluency in English because participants may need to communicate with us after hours and be able to describe symptoms and concerns and follow instructions to treat anaphylaxis
结局指标
主要结局
Desensitization to allergic food as assessed by change in maximum tolerated dose in a dichotomous manner
时间窗: month 0, month 18
Change in how much nuts the participant can eat without an allergic reaction after the low dose OIT assessed as dichotomous did the participant reach 5 times the baseline eliciting dose
Immunological change in IgG4
时间窗: month 0, month 18
Change in allergen specific immunoglobulin G4 (IgG4) from baseline to end
次要结局
- Desensitization to allergic food as assessed by change in maximum tolerated dose on a linear scale(month 0, month 18)
- Immunological change in IgG4(pre-study, month 18)
- Desensitization to allergic food as assessed by maximum tolerated dose(month 0, month 18)
研究者
Julia Upton
Principal Investigator
The Hospital for Sick Children