Food Challenge at Home or in Medical Practice - a Multi-center Randomized Control Trial - FoodCHOMP Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Proportion of participants experiencing immune-mediated adverse events during food challenge
研究概览
简要总结
This is a pilot, multi-centre, randomised clinical trial evaluating the safety and feasibility of a home-based oral food challenge in adults with low-risk food allergy labels. Eligible participants are aged 18 years or older and have a self-reported food allergy with negative skin prick testing to the implicated food. Participants will be randomised to either a home-based or standard in-clinic food challenge. The primary aim is to determine the safety of home challenges, measured by the rate of immune-mediated adverse events. Secondary aims include feasibility of recruitment and delivery, protocol adherence, quality of life, and food reintroduction outcomes.
详细描述
Food allergies are highly prevalent and contribute to significant patient anxiety and healthcare utilisation. Many individuals carry food allergy labels without confirmation through diagnostic food challenge, resulting in unnecessary food avoidance. In-clinic food challenges are the current standard for confirming tolerance but are resource-intensive and often delayed. This study evaluates whether selected low-risk adults can safely complete a structured oral food challenge at home.
This is a pilot, multi-centre, randomised controlled trial conducted at two tertiary allergy centres in Victoria, Australia (Austin Health and Royal Melbourne Hospital). Adults referred with a reported food allergy will undergo clinical assessment and skin prick testing. Those with negative skin testing (<3mm wheal) to the implicated food and meeting other eligibility criteria will be randomised 1:1 to either:
- Intervention: Home-based oral food challenge over five days, beginning with a single supervised dose in-clinic and followed by four incremental doses at home with daily clinical follow-up.
- Control: Standard in-clinic oral food challenge using a protocol derived from PRACTALL and ASCIA guidelines.
The primary outcome is the proportion of participants experiencing an immune-mediated adverse event during food challenge. Secondary outcomes include feasibility metrics (eligibility, recruitment, delivery), non-immune mediated adverse events, protocol adherence, quality of life (measured by FAQLQ-12), time to challenge, and real-world food reintroduction.
The study will enrol 120 participants (60 per arm). Outcomes will inform the design of a future non-inferiority trial and may support integration of home challenges into routine practice for selected patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Negative (<3mm) fresh or extract skin testing to the food implicated within their allergy label
- •Aged greater than 18 years
排除标准
- •Evidence of prior sensitisation to challenge food 0 Defined as previously positive skin testing or allergen specific IgEs if available
- •Pregnancy
- •Patients with poorly controlled asthma - defined as an ACQ5 scores >1 at the time of enrolment
- •Patients with a history of food reactions that is not-consistent with an IgE mediated process; i.e. exclusively gastrointestinal symptoms, FPIES
- •Patients with a clear history of food-dependent exercise induced anaphylaxis
- •Patients on a concurrent medication which may influence the outcome of the challenge;
- •Antihistamine therapy; Patients receiving more than stress dose steroids (i.e. > 50mg QID hydrocortisone [or steroid equivalent]); Omalizumab
- •Any other illness that, in the investigator's judgement, will substantially increase the risk associated with subject's participation in this study
结局指标
主要结局
Proportion of participants experiencing immune-mediated adverse events during food challenge
时间窗: During the food challenge period (Days 1-5 post-randomisation)
Immune-mediated adverse events are defined as clinical symptoms consistent with IgE-mediated food allergy occurring during the food challenge, including but not limited to: urticaria, angioedema, vomiting, diarrhoea, or respiratory compromise (e.g., wheezing, cough, stridor). Events will be recorded according to a standardised adverse event form. For home challenges, participants will self-report symptoms daily and receive follow-up via nursing staff. In-clinic events will be recorded by supervising clinicians.
次要结局
- Proportion of screened patients who are eligible for randomisation (Eligibility-to-screened ratio)(Baseline visit)
- Proportion of eligible patients who consent to participate (Recruitment-to-eligibility ratio)(At consent discussion (baseline visit))
- Proportion of randomised participants who receive the allocated intervention (Intervention-to-recruitment ratio)(Day 1 to Day 5 (intervention delivery period))
- Difference in proportion of participants tolerant to challenge food(At completion of challenge (Day 5))
- Time from clinic referral to challenge completion(From the date of referral for food challenge to date of challenge completion or withdrawal from the study assessed up to 60 months.)
- Proportion of participants experiencing non-immune mediated adverse events(Day 1 to Day 5 (challenge period))
- Proportion of participants with severe adverse reactions (anaphylaxis or death)(Day 1 to Day 5 (challenge period))
- Change in Food Allergy Quality of Life (FAQLQ-12) score from baseline(Baseline and 6 months post-randomisation)
- Proportion of participants consuming the challenge food post-trial(At 6-month follow-up)
研究者
Jack Godsell
Dr Jack Godsell, Clinical Immunologist and Allergist, Principal Investigator
Austin Health