Hypoallergenicity, Growth Parameters and Tolerance of a Pectins Thickened Hydrolysed Rice-proteins (PTRHF) based Formula in Infants Allergic to Cow’s Milk: Intermediate Analysis - EAP 2021 Virtual Congress and MasterCourse

Roberto Berni-Canani ¹ Elena Bradatan ² Laura Carucci ¹ Serena Coppola ¹ Linda Cosenza ¹ Tommaso Cozzolino ¹ Veronica Giglio ¹ Nicolas Kalach ³ Anaïs Lemoine ⁴ Rita Nocerino ¹ Mélanie Rapp ⁴ Patrick Tounian ⁴

¹Pediatric Allergy Program Department of Translational Medical Science and ImmunoNutritionLab, Ceinge Advanced Biotechnologies University Federico II Naples, Italy
²Department of Pediatrics, Namur Regional Hospital, Namur, Belgium
³Pediatric Department, Saint Antoine Clinics of Pediatrics, Saint Vincent de Paul Hospital, Groupement des Hopitaux de l’Institut Catholique, Lille, France
⁴Department of Pediatric Nutrition & Gastroenterology, Armand Trousseau Hospital, Paris, France

Background: Cow`s milk allergy (CMA) is managed by eliminating cow milk proteins from infants’ diet.

Objective: To evaluate the hypoallergenicity of a Thickened Hydrolysed Rice-proteins based Formula (PTRHF, Novarice®, United Pharmaceuticals, Paris), according to American Academy of Paediatrics’ criterias, in children with Immunoglobulin E(IgE)-mediated and non-IgE-mediated CMA.

Methods: 1 to 36 months old infants, with CMA, suspected or proven by a Double-Blind Placebo-Controlled Food Challenge (DBPCFC) in the previous 2 months and asymptomatic for at least one week were included. First, children underwent a DBPCFC with the TRHF on 2 days one week apart. Those with undiagnosed CMA were given a cow milk-based formula under same conditions over a third day. Patients with confirmed CMA and tolerating the TRHF were exclusively formula-fed the TRHF during 6 months. Potential allergic symptoms, safety and anthropometric parameters were monthly assessed.

Results: 4 hospitals in Italy, France and Belgium included 32 patients (mean age: 7.9 (±5.3) months). 2 had no CMA, and CMA could not be confirmed for a third one because of too many deviations, leading to 29 patients with proven CMA (IgE-mediated for 13). Neither immediate nor delayed allergic reactions occurred after ingestion of minimum 190 ml of PTRHF (3 g of proteins). All patients started exclusive TRHF-feeding, except for one whose parents refused their child pursued the study participation. Allergic symptoms, absent at inclusion, did not appear. The mean weight-for-age z-score significantly increased from -0.7 (±0.9) to 0.4 (±0.8). Globally, 34 adverse events occurred in 21 subjects, 2 were serious, with none related to PTRHF composition, nor leading to study or feeding discontinuation.

Conclusion: All children with CMA tolerated the PTRHF. This hypoallergenic formula is safe and secures allergic children growth.

This pectins thickened rice proteins-based formulae is a suitable alternative.