A Randomized Controlled Trial of Oral Immunotherapy Versus Allergen Avoidance in Children Under 2 Years With Food Allergy

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Oral Food Challenge Response at End of Treatment — End of treatment, approximately 18-24 months after randomization
  Effect of oral immunotherapy will be assessed by oral food challenge (OFC) at the end of treatment and compared with the control arm. Participants will be classified into predefined response categories: successful responders, defined as participants tolerating a 4000 mg food protein OFC; partial responders, defined as participants with an increased reaction threshold to at least 1000 mg food protein but not tolerating the final 4000 mg OFC and/or experiencing difficulties during up-dosing; and non-responders, defined as participants discontinuing OIT due to allergic reactions or having a reaction threshold below 1000 mg food protein.
• Difficulty With Up-dosing During Oral Immunotherapy — During the up-dosing phase, approximately 0-6 months after treatment initiation.
  Difficulty with up-dosing will be assessed in participants randomized to the OIT group. Difficulty is defined as allergic reactions, dose reductions, delayed dose escalation, temporary treatment interruption, or inability to complete the planned up-dosing phase according to protocol.
• Sustained Unresponsiveness — 24-30 months after initial randomization, corresponding to approximately 6 months after completion of OIT.
  Sustained unresponsiveness will be assessed by oral food challenge (OFC) after 6 months of either avoidance or regular intake of the allergenic food, according to randomization after completion of OIT. Success of the OFC will indicate potential long-term tolerance rather than transient desensitization.

Trial sites (1)

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