Background: Food allergy is the most common cause of atopic symptoms in early childhood. Standard care is an exclusion diet to avoid symptoms, but is associated with a risk of nutritional deficiencies. Sinlac® is a rice- and carob-based infant cereal free from major allergens, providing full nutritional support for children suffering from food allergies. Apple polyphenols (AP) have been shown to have favorable anti-allergy properties.
Methods: A randomized clinical trial (NCT01029184) based on open-label food challenges was conducted to compare the tolerability of Sinlac® cereals with or without AP, with that of well-known allergenic foods, in subjects with severe food allergy (aged 4-40 months). Study products were Sinlac®, Sinlac®AP (0.3% in matrix), wheat, potato, milk and hen’s egg. The primary endpoint was a positive reaction to open-label food challenges.
Results: Of the 51 subjects randomized, 48 completed the study. Both Sinlac® and Sinlac®AP were significantly better tolerated by atopic infants than other allergenic foods: incidence of allergic reactions was 2% with Sinlac® and Sinlac®AP, versus 49% with wheat, potato, milk or hen’s egg.
Conclusion: Sinlac® and Sinlac®AP are very well tolerated and offer a nutritionally balanced option for atopic infants and children. Studies are needed to assess the benefit of adding AP to low allergenic products.