High Tolerability of a Rice and Carob-Based Cereal Demonstrated in Highly Allergic Infants and Children: A Randomized Open-Food Challenge TrialBauer F1, Singh A2, Zotl B3, Seng D3, Bauer CP3*, Pecquet S4, Steenhout P4 and Nutten S2
- *Corresponding Author:
- Carl Peter Bauer
Kinderarzt-Allergologie-Sportmedizin, Fachklinik GaiBach
Kinderarzt-Allergologie-Sportmedizin, DorfstraBe 1 - 83674
GaiBach bei Bad Tolz, Germany
Tel: +49 8041 798-221
Fax: +49 8041 798-222
E-mail: [email protected]
Received date: December 06, 2016; Accepted date: December 23, 2016; Published date: December 31, 2016
Citation: Bauer F, Singh A, Zotl B, Seng D, Bauer CP, et al. (2016) High Tolerability of a Rice and Carob-Based Cereal Demonstrated in Highly Allergic Infants and Children: A Randomized Open-Food Challenge Trial. J Allergy Ther 7:244. doi: 10.4172/2155-6121.1000244
Copyright: © 2016 Bauer F, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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.