Home-based double-blind placebo-controlled food challenges are effective in the diagnosis of delayed gluten or milk hypersensitivity in children, reducing the need for elimination diets, as reported in a recent trial.
The management of food hypersensitivity is mainly based on the elimination or avoidance of the culprit food. Eliminating milk protein and gluten from the diets of individuals with relevant allergies is a challenging step. Elimination diets also affect social relationships and instigate stigma. Therefore, it is crucial to identify and avoid unnecessary elimination diets among pediatric populations.
A randomized, controlled study published in the Journal of Allergy and Clinical Immunology aimed to assess the effectiveness of a home-based, double-blind placebo-controlled food challenge, or H-FC, in reducing unnecessary elimination diets in children.
Study Participant
The study enrolled 73 children who were on a strict elimination diet for 3 to 180 months prior to the assessment. Of these participants, 39 had eliminated both milk protein and gluten, and 52 children had also eliminated other foods. The participants were further categorized into two groups, with 40 children undergoing two challenge periods and 33 children undergoing three challenge periods.
Food Challenge Outcomes
H-FC yielded positive outcomes in 18 of the 73 children. In addition, 70% of gluten challenges and 89% of milk challenges yielded negative results. Half of the positive challenges had the active ingredient during the initial challenge period, followed by a placebo for the second challenge period. The challenge positive results were significantly lower in the three-period crossover than in the two-period crossover (p < 0.05).
Re-Introduction of Gluten and Milk Protein
During the follow-up, 80% of participants with negative challenges had successfully re-incorporated gluten or milk protein into their diet. Four participants with a positive gluten challenge re-incorporated gluten in their diet 1-4 years after H-FC. However, 11 children continued on an elimination diet despite negative challenges.
Human Leukocyte Antigen Haplotype and Immunoglobulin E Levels
Approximately 53% of the children subjected to the gluten challenge were found to have human leukocyte antigen HLA-DQ2/8 haplotype. Wheat-specific IgE was present in 13 participants with gluten sensitivity. Wheat-specific IgE levels were estimated to be ≤ 1.5 kU/L in two children with a positive wheat challenge.
Hypersensitivity Symptoms and Food Challenge Results
All children with positive H-FC reported gastrointestinal symptoms on exposure to allergens, with one child experiencing eczema exacerbation and three children experiencing extraintestinal symptoms.
In summary, the H-FC is an effective tool for the diagnosis of delayed hypersensitivity to gluten or milk in children. The majority of the children with negative H-FC were successful in the re-introduction of these components in the diet.
Source:
Landaas, V. Ø., Skjerven, H. O., Carlsen, K. C. L., Størdal, K., & Håland, G. (2023). Home-based double-blind placebo-controlled challenges for diagnosis of delayed gluten/milk hypersensitivity in children. The Journal of Allergy and Clinical Immunology: In Practice,12(3), 652–659.e5. https://doi.org/10.1016/j.jaip.2023.12.032
