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A Hypoallergenic Infant Formula Comprising Extensively Hydrolyzed

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A Hypoallergenic Infant Formula Comprising Extensively Hydrolyzed Central Journal of Human Nutrition & Food Science Bringing Excellence in Open Access Research Article *Corresponding author Esther Matencio, Department of Research and Development, Hero Spain S.A., Avda. Murcia 1, 30820 Alcantarilla, Murcia, Spain, Tel: 34-968-898- A Hypoallergenic Infant Formula 900; Fax: 34-968-800-727; Email: Submitted: 27 June 2016 Comprising Extensively Hydrolyzed Accepted: 20 July 2016 Published: 22 July 2016 Protein for the Nutritional ISSN: 2333-6706 Copyright Treatment of Infants with Cow’s © 2016 Matencio et al. OPEN ACCESS Milk Allergy: Safety, Tolerance and Keywords • Cow’s milk protein allergy • Extensively hydrolyzed infant formula • Immunity Efficacy • Infant formula Esther Matencio1*, José Maldonado2,7, Josune Olza3-5, M Dolores Mesa3,5,7, • Long chain polyunsaturated fatty acids Fernando Romero1, Gaspar Ros6, Pedro Abellán1 and Ángel Gil3-5 1Research and Development Department, Hero Spain S.A., Avda. Murcia 1, 30820, Alcantarilla, Murcia, Spain 2Hospital Virgen de las Nieves, Avda. de las Fuerzas Armadas, 2, 18014 Granada, Spain 3Institute of Nutrition and Food Technology “José Mataix”, Department of Biochemistry, and Molecular Biology II, University of Granada, Biomedical Research Center, Avenida del Conocimiento s/n, 18100 Armilla, Granada, Spain 4CIBER Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Madrid, Spain 5Instituto de Investigación Biosanitaria ibs.GRANADA, Spain 6Department of Food Science and Nutrition, Faculty of Veterinary Sciences, University of Murcia, Campus de Espinardo, 30071 Espinardo, Murcia, Spain 7Retics funded by the PN I+D+I 2008-2011 (SPAIN), ISCIII- Sub-directoratee General for Research Assessment and Promotion and the European Regional Development Fund (ERDF), Ref. RD 12/0026 Abstract Background: There is strong evidence about the role of extensively hydrolyzed formula (eHF) in the treatment of cow’s milk protein allergy (CMPA). The main objective of this work was to ensure an adequate nutritional support for cow’s milk protein allergic infants. Methods: An eHF was designed, and this eHF was validated by means of in vitro and in vivo studies and subsequently in a clinical trial. In vitro studies and Active Systemic Anaphylaxis Test (ASA test) established antigenicity. A prospective clinical trial was performed to evaluate the safety and tolerance of this formula for use in infants with proven CMPA. The safety and clinical tolerance was evaluated by means of an oral food challenge provocation test (OFC). Also, LCPUFAs in red blood cells and cytokines in plasma were measured in a subgroup of infants with CMPA. Results: Of the 47 infants included with proven CMPA, only one showed a positive result in the OFC, meaning that the eHF was tolerated by 98% of the infants. Next, 30 infants were fed with the eHF for 3 months: One infant developed a cutaneous eruption during the 1st month of the follow-up and dropped out. During the 2ndand 3rd month of the intervention, no infants exhibited symptoms. Furthermore, the eHF allowed the infants to experience normal weight gain within the 3 months study period. Conclusion: In accordance with current guidelines, this eHF was tolerated by more than 90% of infants with proven CMPA. ABBREVIATIONS INTRODUCTION CMPA: Cow’s Milk Protein Allergy; eHF: Extensively Recent decades have seen an increase in the number of Hydrolyzed Formula; LCPUFAs: Long Chain Polyunsaturated people suffering allergic diseases in developed countries [1] and Fatty Acids; OFC: Oral Food Challenge Provocation Test; DHA: there is growing evidence of a relation between the development Docosahexaenoic Acid; AA: Arachidonic Acid; WHO: World of allergies in early life and its later consequences [2]. Health Organization; IgE: Immunoglobulin E The immune system of infants at birth may be fully Cite this article: Matencio E, Maldonado J, Olza J, Mesa MD, Romero F, et al. (2016) A Hypoallergenic Infant Formula Comprising Extensively Hydrolyzed Protein for the Nutritional Treatment of Infants with Cow’s Milk Allergy: Safety, Tolerance and Efficacy. J Hum Nutr Food Sci 4(3): 1090. Matencio et al. (2016) Email: Central Bringing Excellence in Open Access developed, but is still immature and has to be programmed. Th2 their infants have been treated with DHA to study the prevention of allergies [10,11]. However, there is still a gap about the role reached with Th1 predominance. Allergens are proteins that are of DHA in the tertiary prevention of allergy. Only in vivo animal recognizedpredominance as “foreign”has to be byinverted the immune until a system,normal adultwhich profile triggers is studies seem to have evaluated the action mechanisms [12] and an immune/allergic response against these antigens. Cow’s milk some clinical trials have mentioned the possible role of DHA in the tertiary prevention or treatment of allergy [13,14]. come into contact with the newborn [1,3]. Indeed, CMP is the The main objective of the present study was to assess the leadingprotein cause(CMP) of may food be allergy considered in infants as andthe firstchildren food younger allergens than to casein and 80% hydrolyzed whey proteins) in a group of infants of 2% - 3% in the infant population [1]. Most infants with CMPA safety, tolerance and efficacy of a new eHF (20% hydrolyzed three. CMPA seems to peak in the first year of life, with a prevalence [6,7]. Secondary outcomes included the analysis of selected 85% become clinically tolerant by the third year of life. CMPA diagnosed with CMPA according to current scientific guidelines develop symptoms in the first year of life and approximately plasma cytokines and long chain polyunsaturated fatty acids (LC- PUFAs) in red blood cells in a subgroup of infants diagnosed with the abnormal immune response of the host after ingestion of CMPA, before and after nutritional treatment with the eHF. theseis defined CM proteins. by the occurrenceCMPA can beof dividedclinical intosymptoms IgE-mediated related and to MATERIALS AND METHODS appear immediately or within two hours after the intake, while Study population innon-IgE-mediated non-IgE-mediated CMPA. CMPA, In symptomsthe first case, may symptomstake a long usually time to appear - perhaps delayed reactions become manifest only This was a prospective, open, multicenter study conducted after 48 hours or even 1 week following ingestion [4]. Patients between January 2010 and December 2012 in different hospitals with CMPA develop gastrointestinal symptoms (vomiting, in Spain (Hospital Virgen de las Nieves (Granada), Hospital diarrhea, colic, constipation…), skin symptoms (erythema, atopic dermatitis, angioedema…), respiratory symptoms (sibilance, Gregorio Marañón (Madrid)). The study was approved by Ethics bronchospasm), anaphylaxis, and failure-to thrive [4,5]. In most CommitteeVall D’Hebrón of the(Barcelona); La Paz Hospital Hospital acting Infant as a theSofía leading and Hospital center, of the populations studied, there are overlapping symptoms. and by similar bodies of each participating center. A written informed consent was obtained from each infant’s parents The treatment for CMPA in infants involves the complete before the challenge testing with the new extensively hydrolyzed elimination of CMP from the diet and adequate replacement with formula. This study was performed according to Good Clinical Practice guidelines and conform the Helsinki Declaration. The for infants from birth up to six months is human milk and breast- inclusion criteria were: Infants diagnosed with CMPA based feeding;a hypoallergenic only in formulacases where [4-7]. breast-feeding The gold standard is not and possible, first choice an on clinical history of IgE-mediated CMPA, acute cutaneous infant formula specially designed for the nutritional treatment of symptoms (erythema, urticaria, angioedema), which seemed to infants can be used [4-7]. be related with the intake of cow’s milk, a positive test in IgE Extensively hydrolyzed formulas (eHFs) are recommended for formula-fed infants diagnosed with CMPA. Such formulas are exceptantibodies when specific the challenge to cow’s milkwas andcontraindicated or milk protein in accordance(skin prick CMPA according to current international guidelines [4,5]. Only withtest (SPT) recent and/or guidelines measure-specific [4]. Infants were IgE antibodies) excluded if andthey OFC had test, any whenthe first infants option are in allergic the nutritional to extensively treatment hydrolyzed of the infants formulas, with a serious gastrointestinal tract diseases other than CMPA or lactose next step could be to use amino acid-based formulas [5]. intolerance, congenital cardiovascular, kidney, liver diseases, and other diseases which could mask the study results. According to international guidelines [6-8], to claim that a hypoallergenic formula is suitable for the nutritional treatment Study design of infants with CMPA, it is necessary to test the hypoallergenicity Forty seven infants (26 boys, 21 girls; age 4.6 ± 1.8 months by means of clinical trials and to demonstrate that this formula (mean ± SD) who had been previously diagnosed with CMPA, were selected for the study. A diagnosis of immediate hypersensitivity with CMPA. Only some eHFs and amino acid-based formulas to CMPA was made according to the following criteria: suggestive (AAFs),is tolerated which by are at consideredleast 90% non-allergenic,(with 95% confidence) meet these of criteria.infants clinical history based on the occurrence of acute symptoms However, from an organoleptic point of view, these formulas within 2 hours after the ingestion of a cow’s milk-based formula, are characterized by an unpleasant taste and bitterness [5-7,9], Which could negatively affect their acceptance by infants and even parents. It is important therefore to try to improve the procedure.milk-specific immunoglobulin IgE as indicated by positive SPT palatability of these products in order to avoid problems related or high serum milk specific IgE levels and/or positive challenge with the (optimal) growth of infants with CMPA due to the low Skin prick tests were performed according to standard intake of formula. procedures with 5% wt/vol whole cow’s milk (Alergia Related to the prevention of allergies in the early stages of ® Chemi cal).
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