Tolerancia y eficacia de una fórmula extensamente hidrolizada en lactantes con alergia a proteínas de leche de vaca mediada por IgE. Estudio JUNGLO (I)hidrolizado extenso de caseína
- P. Ibáñez
- Alfonso Solar Boga
- J. Maldonado
- Santiago Nevot Falcó
- Elena Alonso Lebrero
- A. M. Plaza
- Francisco Cañabate Reche
- P. Codoñer
- Beatriz Espín Jaime
- A. Rodríguez Herrera
- Carmen Escudero Cantó
- S. Sánchez
- J. Brasy
- Federico Lara Villoslada
- C. Fressange Mazda
- P. Le Ruyet
- José Manuel Moreno Villares
ISSN: 0001-6640
Year of publication: 2016
Volume: 74
Issue: 3-4
Pages: 83-90
Type: Article
More publications in: Acta pediátrica española
Abstract
Objectives: The main objective of this study was to evaluate the tolerance of a new casein hydrolyzate formula, and its efficacy during a 3 months consumption period by infants with IgE-mediated cow’s milk protein allergy (CMPA). Methods: This study was part of randomized, double blind study performed in 15 Spanish hospitals. In the present paper the results of the arm that received an extensively hydrolyzed casein formula are reported. Full term infants aged up to 9 months were included to check that 97% of them tolerate the formula at introduction. The CMPA was confirmed by a specific IgE dosage before inclusion. An oral food challenge was made with the formula. Over 3 months, the evolution of the clinical symptoms and the growth were evaluated. Results: The 25 boys and 22 girls included tolerated the formula at introduction without any adverse reaction during the first day of formula intake, meaning that 97% of the infants tolerated the treatment at introduction (p= 0.0112). Three adverse events were reported 4, 6 and 10 days later and were considered possibly or probably related to the study formula indicating an effective delayed tolerance of more than 93% of infants. At 1 month of follow-up, the condition of the infants was greatly improved as indicated by the dramatic decrease of the digestive symptoms from 40.4% to 13%, and the total regression of all the other symptoms. The growth of the infants over 3 months showed a normal pattern, in agreement with the World Health Organization (WHO) growth references. Conclusion: This new casein hydrolyzate formula shows a rate of tolerance >97%, it is efficient to rapidly improve clinical symptoms and allows a normal growth pattern in infants with CMPA.