Actively Recruiting
A Pragmatic, Open-label Study of Peanut Oral Immunotherapy in Inducing Desensitisation or Remission in Children With Food Allergy Compared to Standard Care (Strict Allergen Avoidance)
Led by Chinese University of Hong Kong · Updated on 2026-05-19
125
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the real-world effectiveness, safety, and tolerability of peanut oral immunotherapy (OIT) in children aged 2 to 17 years with confirmed peanut allergy in Hong Kong. This open-label, non-randomized trial addresses the need for practical evidence beyond controlled clinical trials to make peanut OIT a more accessible option. The study also aims to identify biomarkers linked to successful treatment and to establish a model for future food allergy therapies in the region. Participants will be assigned to one of two groups: an intervention group receiving 18 months of standardized peanut OIT using defatted peanut powder, or a control group following strict peanut avoidance for the same duration. Allocation is in a 4:1 ratio favoring the treatment group. The primary goal is to measure the proportion of children achieving desensitization to over 640 mg of peanut protein after 18 months. During the study, children will undergo oral food challenges to assess desensitization and have monitoring for treatment-related side effects. Researchers will systematically record adverse events and study reasons for discontinuation. Blood samples will be collected to analyze plasma protein biomarkers before and after treatment. The study will last 18 months per participant, with ongoing safety and efficacy assessments throughout.
CONDITIONS
Brief Title
Pathway to Peanut Tolerance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parent or guardian can provide informed consent
- Aged 2 to 17 years
- Any sex
- Any race or ethnicity
- History of peanut allergy confirmed by positive skin prick test or peanut-specific IgE test
You will not qualify if you...
- Conditions contraindicating adrenaline use (e.g., hypertension, cardiac rhythm disorders)
- Chronic diseases requiring therapy other than asthma, atopic dermatitis, or allergic rhinitis
- Major illness affecting ability to participate
- Currently receiving allergen immunotherapy
- Participation in other food allergy treatment trials or biologic therapy within past year
- Uncontrolled or moderate to severe asthma with lung function under 80% predicted for those aged 7 or older
- Gastrointestinal eosinophilic disorders
- Use of certain antihistamines shortly before allergy testing
- Use of beta-blockers, ACE inhibitors, angiotensin-receptor blockers, or calcium channel blockers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 18 months
Participants in the active arm undergo peanut oral immunotherapy, while participants in the control arm follow strict peanut avoidance.
Trial Site Locations
Total: 1 location
1
Department of Paediatrics, Prince of Wales Hospital
Hong Kong, Hong Kong
Actively Recruiting
Research Team
S
Sze Yin Agnes Leung, MBChB
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here