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A Randomized Controlled Trial of Oral Immunotherapy Versus Allergen Avoidance in Children Under 2 Years With Food Allergy
Sponsor: Copenhagen Studies on Asthma in Childhood
Summary
The goal of this clinical trial is to learn whether oral immunotherapy (OIT) is safe and effective for treating food allergy in children aged 0-2 years with peanut, tree nut, or sesame allergy. The study also aims to identify biological mechanisms and biomarkers associated with natural tolerance development and successful OIT using a systems biology approach. The main questions it aims to answer are: 1. Does oral immunotherapy increase the likelihood of successful desensitization and sustained unresponsiveness compared with allergen avoidance? 2. Can immune, microbiome, metabolomic, genetic, and epigenetic profiles predict treatment response, natural tolerance development, and long-term outcomes? Researchers will compare children receiving oral immunotherapy with children receiving standard care (allergen avoidance) to determine differences in treatment success, sustained unresponsiveness, safety, quality of life, and biological markers. Participants will: * Be randomized to either oral immunotherapy or allergen avoidance for 18-24 months. * Undergo oral food challenges at study visits to assess allergic reactivity and treatment outcomes. * Provide blood, urine, hair, skin swabs, skin tape strips, throat swabs, nasal lining fluid, and stool samples at baseline and at the end of the study for immune, microbiome, metabolomic, gene expression, and epigenetic analyses. * Complete allergy assessments, including skin prick testing and clinical evaluations. * Have allergic symptoms, adverse reactions, and development of other allergic diseases monitored throughout the study. * Have parents complete questionnaires assessing food allergy-related quality of life, anxiety, and coping.
Official title: A Systems Biology Approach to Treatment of Food Allergy: A Randomized Controlled Trial of Oral Immunotherapy in Children Under 2 Years (SAFARI)
Key Details
Gender
All
Age Range
Any - 24 Months
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-09
Completion Date
2031-06
Last Updated
2026-09-17
Healthy Volunteers
No
Interventions
Oral immunotheraphy (OIT)
Daily OIT will be administered with the relevant food allergen. Treatment includes gradual dose escalation over approximately 6 months, followed by a 12-month maintenance phase with daily intake of 300 mg food protein. Assessment of sustained unresponsiveness: Following completion of OIT and a successful end-of-treatment oral food challenge, participants in the OIT arm will undergo a second 1:1 randomization to either continued regular allergen consumption or allergen avoidance. After an additional 6 months, participants will undergo another oral food challenge to assess sustained unresponsiveness.
Locations (1)
Department of Paediatrics, Herlev Hospital
Herlev, Capital Region, Denmark