Comparison of Protocols for Re-introducing Tree Nuts in Patients With Allergy to Tree Nuts
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of patients who adhere to each procedure (A or B).
研究概览
简要总结
This study aims to compare the safety and the compliance to different procedures (A: at home or B: at the hospital) for introducing tree nuts into the diet of patients with Immunoglobulin E (IgE)-mediated allergy to the aforementioned nuts. In parallel, the effectiveness of tree nuts' introduction in respect to tolerance induction compared to the standard care (strict avoidance of tree nuts) will be evaluated.
详细描述
This is a multi-centered observational study comparing the safety and compliance of different procedures for introducing tree nuts into the diet of patients with IgE-mediated allergy to nuts. The effectiveness of tree nuts' introduction in respect to tolerance induction compared to the standard care (strict avoidance of tree nuts) will also be evaluated.
The study will be contacted in the Department of Allergy and Clinical Immunology, 2nd University Pediatric Clinic of "Panagiotis & Aglaia Kyriakou" Children's Hospital, Athens, Greece, in collaboration with the Allergy Unit "Dimitrios Kalogeromitros, 2nd University Clinic of Dermatology and Venereology, "Attikon" University Hospital, University of Athens, Greece and the Allergology Department of "Laiko" General Hospital, Athens, Greece.
The study will include participants with persistent IgE mediated allergy to tree nuts (including at least walnut or pistachio) who are willing to follow one of the two induction procedures (A: at home, B: at the hospital) and voluntarily provide written consent in the procedures and the goals of the study. Participants will adhere to one of the two induction procedures according to their preferences. Groups will be matched in respect to the number of participants.
Participants who have already followed one of the two procedures can participate following written informed consent.
The control group consists of participants who do not wish to introduce tree nuts into their diet but will consent to provide their medical data and the results of their allergology work-up for research purposes. The target ratio between active and control groups will be 3:1.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent from adult participants or parent/guardian for children. Written assent from participants above the age of 12 years.
- •Male or female participants aged 5 through 40 years, in a good general health condition according to the participant's medical history and the clinical examination and no chronic diseases, except:
- •Allergic rhinitis
- •Asthma controlled with therapy steps 1-3 according to Global Initiative for Asthma (GINA)
- •Well-controlled atopic dermatitis.
- •SPT to tree nut's extract and/or the natural tree nut (Prick-to-Prick) ≥ 3 mm (the largest diameter of the wheal) and serum IgE to tree nut of ≥ 0.35 kUA/L.
- •sIgE > 0.1 kUA/L to at least one seed storage protein of the offending tree nut, except for pistachio, where Ana o 3 will serve as a sensitization marker.
- •Positive baseline OFC, at any dose but the final, conducted following PRACTALL (Practical Issues in Allergology, Joint United States/European Union Initiative) / iFAAM (Integrated Approaches to Food Allergen and Allergy Risk Management) guidelines.
- •Exclusion of active co-allergy to walnut, almond or pistachio, unless they are introduced to the diet simultaneously, by a negative open OFC or a recent (within the last two months) history of uneventful digestion, except for pistachio introduction in participants who are co-allergic to cashew.
- •Forced Expiratory Volume at 1 second (FEV1) or Peak Expiratory Flow Rate (PEFR) ≥ 80% of predictive.
- •The participant and/or the legal custodian should agree to comply with the study procedures.
排除标准
- •History of systematic anaphylaxis GRADE 5 according to Sampson (loss of bowel control, respiratory arrest, severe bradycardia and/or hypotension or cardiac arrest, loss of consciousness) or/and during OFC.
- •Recent (within 12 months) initiation of immunotherapy to any allergen.
- •Past or present eosinophilic esophagitis (EoE).
- •Chronic urticaria.
- •Severe or uncontrolled atopic dermatitis.
- •Uncontrolled asthma of any severity or asthma controlled with therapy steps 4-5 according to GINA
- •Concurrent or within 6 months therapy with omalizumab or another monoclonal antibody.
- •Systematically used corticosteroids:
- •Daily for more than a month during the last year,
- •Courses of corticosteroids during the last 3 months.
- •>2 Courses of corticosteroids lasting ≥1 week during the last year.
- •Inability to discontinue antihistamines 4 days before skin prick testing or OFC.
- •Severe immune disease, severe cardiovascular disease, malignancy, chronic infection, poor compliance, and severe psychiatric disorders.
- •Any important clinical condition that can affect the safety of the participant or the results of the study, including but not limited to cardiovascular diseases, malignancies, diseases of the liver and/or the kidneys, hematologic diseases, physiologic, immunologic and endocrinologic diseases.
- •Use of beta-blockers, angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARB).
- •Pregnancy or lactation.
- •History of alcohol or drug abuse.
结局指标
主要结局
Number of patients who adhere to each procedure (A or B).
时间窗: 2 years.
Comparison of the proportion of participants who follow the procedure.
Number and severity of allergic reactions in procedure A and procedure B.
时间窗: 2 years.
Comparison of the frequency and severity of allergic reactions, and the frequency of adrenaline use in two remedies.
Number of participants with tolerance induction after procedure A and B compared to strict avoidance.
时间窗: 2 years.
The proportion of participants in each group who achieve to consume 300mg of tree nut protein at Final Assessment (cumulative dose of 433mg ), if baseline provocation dose was ≤100mg, or 1000mg (cumulative dose 1433mg), if baseline provocation dose was ≥300mg.
次要结局
- Mean change from baseline in Food Allergy Quality of Life Questionnaire- Food Allergy Independent Measure (FAQLQ-FAIM)-Likert scale-questions , range from 1 'not troubled' to 7 'extremely troubled'.(2 years.)
- Comparison of the mean change in the maximum tolerated dose in participants following procedure A compared to procedure B.(2 years.)
- Immunological alterations induced by the two procedures.(2 years.)
研究者
Maria Pasioti
Principal Investigator
National and Kapodistrian University of Athens