Oral Immunotherapy With Partially Hydrolyzed Wheat-Based Cereals: A Pilot Study

Area of Science:

• Allergy and Immunology
• Food Allergy Research
• Pediatric Gastroenterology

Background:

• Oral immunotherapy (OIT) for wheat allergy is under investigation, but severe adverse reactions are common.
• Partially hydrolyzed wheat-based cereals (pHC) were developed to potentially improve OIT safety.
• Previous studies on OIT for wheat allergy are limited.

Purpose of the Study:

• To assess the tolerability of pHC in children with immunoglobulin E-mediated wheat allergy.
• To determine the maximum tolerated dose of pHC during an initial escalation phase.
• To evaluate the safety and feasibility of a wheat allergy OIT protocol using pHC.

Main Methods:

• A multicenter, open-label, pilot study involving children with wheat allergy.
• Involved a 1-day initial escalation phase with stepwise increased doses of pHC.
• Patients who tolerated the escalation phase continued daily pHC consumption for 1-6 months.

Main Results:

• Four out of nine patients discontinued OIT due to mild to severe reactions during the escalation phase.
• Five patients completed the escalation phase and consumed pHC daily.
• Four of these five patients successfully passed a wheat challenge test after 1-6 months of OIT.
• Approximately 60% of adverse events were unrelated to the study product.

Conclusions:

• Partially hydrolyzed wheat-based cereals (pHC) are tolerated by a subset of children with wheat allergy.
• The study provides preliminary evidence supporting pHC as a potential therapeutic option for wheat allergy.
• Further research is warranted to confirm the efficacy and optimize the use of pHC in wheat allergy OIT.