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 / Tolerance and efficacy of an extensively hydrolyzed formula for infants with IgE-mediated cow’s milk protein allergy. JUNGLO study (part I): Extensively hydrolyzed casein formula

Objetivos: El principal objetivo de este estudio fue evaluar la tolerancia de un nuevo hidrolizado de caseína y su eficacia durante un periodo de 3 meses en lactantes diagnosticados de alergia a las proteínas de leche de vaca (APLV) mediada por IgE. Métodos: El estudio forma parte de un ensayo clínico multicéntrico, aleatorizado y doble ciego, que se llevó a cabo en 15 hospitales españoles. En este artículo se presentan los resultados del grupo de tratamiento que recibió un hidrolizado extenso de caseína, comportándose como un estudio observacional. Se incluyeron lactantes diagnosticados de APLV una vez que se confirmó con la titulación de IgE específica, con el fin de comprobar la tolerancia a la nueva fórmula en más del 97% de los niños. La principal variable de estudio fue la tolerancia a la fórmula, y se evaluó mediante una prueba de provocación realizada en el hospital. La evolución de los síntomas clínicos y del crecimiento se evaluó durante un periodo de 3 meses tras la inclusión. Resultados: Se incluyeron 25 niños y 22 niñas. Todos toleraron la introducción de la fórmula de estudio sin reacciones adversas en el primer día, lo que significa que más del 97% de los lactantes toleraron el tratamiento en el momento de su introducción (p= 0,0112). Ocurrieron tres acontecimientos adversos, a los 4, 6 y 10 días de la introducción de la fórmula, que se consideraron posible o probablemente relacionados con la misma, por lo que la tolerancia efectiva fue del 93%. Al cabo de 1 mes de seguimiento, la situación clínica de los lactantes había mejorado, con una disminución del 40,4 al 13% para los síntomas digestivos, y la desaparición total de todos los demás síntomas. El patrón de crecimiento, levemente disminuido al inicio, se normalizó o al menos mejoró a los 3 meses de tratamiento. Conclusiones: El nuevo hidrolizado de caseína se toleró en más del 97% de los lactantes, y mejora los síntomas clínicos de forma rápida en lactantes con APLV mediada por IgE, al tiempo que se mantiene un crecimiento normal (AU)

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 (AU)

Diet and organochlorine contaminants in women of reproductive age under 40 years old.

The diet of the breast-feeding mother impacts on the quality and quantity of the milk that she feeds her child. Milk can be a vehicle for toxins, such as drugs and their metabolites, viruses, nicotine, caffeine, alcohol, and organochlorine molecules such as PCBs, DDT, HCB, HCH and dioxins, which can harm the health of the breast-feeding child. The 24-h recall diet was considered appropriate to adequately study the diet of breast-feeding mothers and was used in the present preliminary study to establish the possible relationship between the food items consumed and the presence of pesticides in her milk. Two groups of randomly selected healthy breast-feeding volunteers aged between 17 and 35 years from two different areas were recruited: 34 from intensive agriculture zone, El Ejido (Almeria), from the "Hospital de Poniente" and 21 urban zone, the city of Granada, from the "Clinico" University Hospital. Application of the Spearman Correlation Test to the results from Almeria showed a certain positive correlation between the total intake of fats and both the p,p'DDD (rho=0.53, p< or =0.05) and methoxychlor (rho=0.48, p< or =0.05) in mature milk, and between the energy supplied by vegetables and the endosulfan-lactone in mature milk (rho=0.50, p< or =0.05). Among the group of breast-feeding women from Granada, there was a strong correlation between the intake of fats and both the p,p'DDT in transition milk (rho=0.90, p< or =0.05) and the p,p'DDD in mature milk (rho=0.90, p< or =0.05). In conclusion, there is a statistically significant relationship between the consumption of fatty foods and some organochlorine molecules and between the consumption of vegetables and pesticides, and the latter relationship occurs in Almeria but not in Granada.

Analysis of organochlorine pesticides in human milk: preliminary results.

In the face of evidence of human milk contamination by organochlorine pesticides, an analysis was performed on samples of milk obtained from healthy lactating women in the provinces of Granada and Almeria in Southern Spain. The samples were obtained by the Neonate Section of the Department of Pediatrics of Granada University Hospital (Neonatology Division) and by the Neonatal Service of Poniente Hospital in El Ejido, Almería. A liquid-liquid extraction procedure was performed. The cleaning of the sample before gas chromatography-mass spectrometry (GC-MS) used silica Sep-Pak. Among other pesticides, aldrin, dieldrin, DDT and its metabolites, lindane, methoxychlor and endosulfan were identified. The presence of these products was confirmed by mass spectrometry. The identification and quantification of these organochlorine molecules is important because they have estrogenic effects.