Assessment of tolerance of a new product (gluten-free grain snack) in children with food allergy to gluten

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The development of a technological scheme for the production of cereal snacks based on the extrusion process with preliminary enzymatic treatment of wheat flour and the use of hydrolysate as a partial replacement for gluten-free raw materials is an urgent task. The use of gluten-free cereal snacks in the diet opens up new possibilities for dietary therapy in patients suffering from various manifestations of food allergy to gluten, making their diet more diverse and meeting their individual needs. The purpose of the research was to clinically evaluate the tolerance of gluten-free cereal snacks in children with PA to gluten. Material and methods. The study included 21 patients (male and female) aged 3 to 17 years with a diagnosed food allergy, including gluten. All children received gluten-free cereal snacks according to their age: children from 3 to 7 years old (n=11) received 50 g (176 kcal) daily, and children aged 8 to 17 years old (n=10) received 100 g (352 kcal) daily for 14 days, in addition to a non-specific hypoallergenic diet excluding highly allergenic foods. On the first day of the study, the patients or one of their parents evaluated the organoleptic properties of the presented product (taste, color, smell) using a 5-point scale (1 - very bad, 5 - excellent), according to a specially designed questionnaire. The assessment of clinical symptoms over time related to skin, gastrointestinal tract, and nervous system was conducted using a second questionnaire, where parents kept a daily «observation log» reflecting the child's well-being and condition, as well as adverse events associated with taking the product. Clinical safety parameters were assessed based on the dynamics of complete blood count and blood immunological parameters (total IgE, specific IgE, and IgG4 antibodies to the studied allergens) at the beginning and end of the consumption period. Results. Daily examinations and patient questionnaires revealed no adverse reactions to the product. No significant differences in body weight were observed at the end of the study (p>0.05). In the results of clinical and immunological blood analysis before and after consuming gluten-free cereal snacks, no significant deviations were observed in the form of an increase in eosinophil count, total IgE, allergen-specific IgE and IgG4 antibodies in peripheral blood. This suggests a favorable clinical safety profile of the proposed product. Conclusion. The study found that consumption of the new product (gluten-free cereal snacks) was well-tolerated by children aged 3 to 17 years with various manifestations of food allergy: no adverse effects of the product or exacerbations of the underlying disease were observed during the 14-day period of gluten-free cereal snack consumption. Therefore, the studied gluten-free cereal snacks can be recommended for children aged 3 to 17 years with various manifestations of gluten FA, in combination with a gluten free diet.