Growth, Safety and Tolerance in Infants Fed Rice Protein Hydrolysate Formula: The GRITO Randomised Controlled Trial.

Data de publicació: 31/12/2024

Autors de IIS La Fe

• Antonio Nieto García

  Autor

• María Nieto Cid

  Autor

• Ángel Mazón Ramos

  Autor

Autors aliens a IIS La Fe

• Lemoine, Anais
• Espin-Jaime, Beatriz
• Salhi, Hocine
• Salamouras, Dimitrios
• Kalach, Nicolas
• de Castellar-Sanso, Roser
• Delgado Ojeda, Jesus
• Navas-Lopez, Victor Manuel

Grups d'Investigació

• Alergia y enfermedades respiratorias de la Infancia

  Investigador Principal

  Miguel Tortajada Girbés

Abstract

Background: Hydrolysed rice formula (HRF) is tolerated by >90% of children with cow's milk protein allergy (CMPA). However, concerns have been raised about potential suboptimal growth in infants fed HRF compared to those fed an extensively hydrolysed milk protein formula (eHF). Aims: To compare growth, safety and tolerance acquisition in infants with CMPA when fed HRF versus eHF. Methods: A multicentre prospective, randomised, double-blind, placebo-controlled food challenge trial was conducted with infants with CMPA. The infants received either HRF or eHF over a 12-month follow-up period. The primary outcome measure was the change from baseline over the study period in weight-for-length expressed as a Z-score. The secondary outcomes were other anthropometric measurements, tolerability and adverse events (AEs). Results: In total, 105 children were enrolled. The weight-for-length measurements were -0.01 (HRF) and -0.29 (eHF) at baseline and 0.29 and 0.05, respectively, at the last visit, with no significant between-group difference (p = 0.28; mixed-effects model). The Z-scores for other anthropometric variables indicated normal growth, with no significant between-group differences. In total, 29 potentially product-related AEs were reported (12 in the HRF group and 17 in the eHF group). A trend was observed toward a faster acquisition of tolerance in the HRF group (median age: 20.4 months) compared to the eHF group (16.3 months), but this was not statistically significant (p = 0.18). Conclusions: HRF demonstrated appropriate growth, acquisition of tolerance and a good safety profile in infants with CMPA, with no significant differences versus eHF. HRF could be considered as an appropriate option in the management of CMPA.

Keywords

• cow's milk protein allergy; hydrolysed rice-based formula; tolerance; children; arsenic