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

Autores de IIS La Fe

• Antonio Nieto García

  Autor

• María Nieto Cid

  Autor

• Ángel Mazón Ramos

  Autor

Participantes ajenos a IIS La Fe

• Lemoine A.
• Espín-Jaime B.
• Salhi H.
• Salamouras D.
• Kalach N.
• de Castellar-Sansó R.
• Delgado Ojeda J.
• Navas-López V.M.

Grupos

• Alergia y enfermedades respiratorias de la Infancia

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. © 2024 by the authors.

Keywords

• Child Development; Double-Blind Method; Female; Humans; Immune Tolerance; Infant; Infant Formula; Male; Milk Hypersensitivity; Milk Proteins; Oryza; Prospective Studies; Protein Hydrolysates; placebo; plant protein; protein hydrolysate; milk protein; protein hydrolysate; anthropometry; Article; body height; body weight; child growth; child safety; clinical outcome; controlled study; double blind procedure; female; follow up; human; infant; male; milk allergy; multicenter study; prospective study; randomized controlled trial; rice; artificial milk; child development; clinical trial; immunological tolerance; milk allergy; Oryza