Food Allergy Clinical Trial
Official title:
Humoral and Cellular Immune Responses in Hen's Egg Oral Immunotherapy
The study determines how a 6 months oral immunotherapy (OIT) program with hen's egg (HE) effects cellular and humoral immune responses in 50 children with HE allergy. Clinical data, transcriptomics and epigenetics are combined and analyzed by advanced system biology methods. This study will provide better understanding of the effects and mechanisms of OIT.
Oral immunotherapy (OIT) is a therapeutic approach, where gradually increasing doses of a
specific food allergen are administered orally. OIT can desensitize up to 80% of children
with persistent food allergy, and in a subset lead to sustained immune tolerance. The
immunologic mechanisms induced by OIT are still poorly understood.
In this randomized cross-over study, 50 children with challenge-confirmed hen's egg (HE)
allergy will be randomized (2:1) to receive either active HE OIT or continue on an avoidance
diet for 6 months after which active OIT is started. The immunological changes induced by OIT
will be compared to the patient's initial status and to that of the patients on an avoidance
diet.
Serum antibody and humoral mediator analyses as well as gene expression of blood mononuclear
cell (PBMC) by genome-wide microarray assays will be studied. PBMCs will be stimulated with
HE allergens and innate immunity agonists, and the differences in the expression profiles of
messenger-RNAs as well as microRNAs will be studied. Single-cell sequencing and sorting of
regulator T cells (Tregs) will be performed focusing on their transcriptomic responses and
gene methylation. Finally, clinical data, transcriptomics and epigenetic changes will be
combined and analyzed by advanced system biology methods.
This study will provide better understanding of the effects and mechanisms of OIT and
identify biomarkers for selection of patients benefitting from personalized OIT.
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