ClinicalTrials.gov
public full text
Public Domain
A Randomized Controlled Trial of Oral Immunotherapy Versus Allergen Avoidance in Children Under 2 Years With Food Allergy
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.
Conceptio Open Archive
Analyze & explore related research in Conceptio
Connect this record directly into your research workflow or AI agent. Explore citations across open repositories, query full text, and export structured proof bundles.
This document is indexed with metadata only: full text is not available in the archive for this record. Open the official source ↗
Related documents
- Potential Role of AGEs in Paediatric Allergies#849610
- Nutritional Status in Children With Food Allergy: Evaluation of a New Supplement#881516
- Maternal-prenatal gut microbiome-systemic metabolome perturbations and TH2-skewed immunity link to offspring gut microbiome disruption and atopic dermatitis susceptibility#375088
- Probiotics in Prevention of Allergies, Obesity and Caries#894476
- Walnuts as an Infant Solid Food for Health#858183
Record · ID 1126422
Retrieved via Conceptio: every document is proof-bundled with source, license, and retrieval metadata.
Retrieved via Conceptio: every document is proof-bundled with source, license, and retrieval metadata.
Bring this data into your agent: Connect via MCP or API · 20 free credits to start · no card required
Read the Docs → · View CLI source on GitHub · Conceptio Open Knowledge Archive
Read the Docs → · View CLI source on GitHub · Conceptio Open Knowledge Archive