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Safety and efficacy of a new extensively hydrolyzed formula for infants with cow's milk protein allergy.
Pediatr Allergy Immunol 2008; 19(4):348-54PA

Abstract

Cow's milk protein allergy (CMPA) is best treated by complete elimination of cow's milk from the diet. For infants with CMPA who cannot be breast-fed, formulas based on extensively hydrolyzed proteins or on amino acids are the preferred substitutes for cow's milk-based formulas. In this study, we compared the tolerance and growth of infants with CMPA who were fed a new extensively hydrolyzed formula containing lactose (eHF) with those who were fed an amino acid formula (AAF). This was a prospective, multi-center, randomized, reference-controlled study. Seventy-seven infants <12 months old with suspected CMPA were enrolled. In 66 of these, CMPA was confirmed by oral challenge in a double-blind, placebo-controlled food challenge (DBPCFC) or by a medical history of severe allergic reaction to cow's milk and a positive skin prick test. These infants were then tested for their reaction to eHF and AAF in a DBPCFC. All infants tolerated both formulas and were randomized to receive either eHF (n = 34) or AAF (n = 32) for 180 days. Growth (weight, length, and head circumference) and tolerance [skin, gastro-intestinal, and respiratory tract symptoms of allergy] were evaluated after 30, 60, 90, and 180 days. There were no significant differences between the two groups in any of the growth measurements. Length and head circumference were similar to Euro-growth standards, but weight was slightly lower. Gastro-intestinal and respiratory tract symptoms of allergy were also similar in the two groups. However, whereas SCORAD scores for atopic dermatitis remained constant throughout the study in infants-fed eHF, there was a slight decrease in those fed AAF. Infants-fed eHF had significantly fewer incidents of vomiting than infants-fed AAF and a significantly higher frequency of soft stools. The new eHF is safe and well tolerated in infants diagnosed with CMPA.

Authors+Show Affiliations

Department of Pediatric Pneumology and Immunology, University Children's Hospital Charité, Berlin, Germany. bodo.niggemann@charite.de

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18167160

Citation

Niggemann, B, et al. "Safety and Efficacy of a New Extensively Hydrolyzed Formula for Infants With Cow's Milk Protein Allergy." Pediatric Allergy and Immunology : Official Publication of the European Society of Pediatric Allergy and Immunology, vol. 19, no. 4, 2008, pp. 348-54.
Niggemann B, von Berg A, Bollrath C, et al. Safety and efficacy of a new extensively hydrolyzed formula for infants with cow's milk protein allergy. Pediatr Allergy Immunol. 2008;19(4):348-54.
Niggemann, B., von Berg, A., Bollrath, C., Berdel, D., Schauer, U., Rieger, C., ... Wahn, U. (2008). Safety and efficacy of a new extensively hydrolyzed formula for infants with cow's milk protein allergy. Pediatric Allergy and Immunology : Official Publication of the European Society of Pediatric Allergy and Immunology, 19(4), pp. 348-54. doi:10.1111/j.1399-3038.2007.00653.x.
Niggemann B, et al. Safety and Efficacy of a New Extensively Hydrolyzed Formula for Infants With Cow's Milk Protein Allergy. Pediatr Allergy Immunol. 2008;19(4):348-54. PubMed PMID: 18167160.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of a new extensively hydrolyzed formula for infants with cow's milk protein allergy. AU - Niggemann,B, AU - von Berg,A, AU - Bollrath,C, AU - Berdel,D, AU - Schauer,U, AU - Rieger,C, AU - Haschke-Becher,E, AU - Wahn,U, Y1 - 2007/12/19/ PY - 2008/1/3/pubmed PY - 2009/6/2/medline PY - 2008/1/3/entrez SP - 348 EP - 54 JF - Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology JO - Pediatr Allergy Immunol VL - 19 IS - 4 N2 - Cow's milk protein allergy (CMPA) is best treated by complete elimination of cow's milk from the diet. For infants with CMPA who cannot be breast-fed, formulas based on extensively hydrolyzed proteins or on amino acids are the preferred substitutes for cow's milk-based formulas. In this study, we compared the tolerance and growth of infants with CMPA who were fed a new extensively hydrolyzed formula containing lactose (eHF) with those who were fed an amino acid formula (AAF). This was a prospective, multi-center, randomized, reference-controlled study. Seventy-seven infants <12 months old with suspected CMPA were enrolled. In 66 of these, CMPA was confirmed by oral challenge in a double-blind, placebo-controlled food challenge (DBPCFC) or by a medical history of severe allergic reaction to cow's milk and a positive skin prick test. These infants were then tested for their reaction to eHF and AAF in a DBPCFC. All infants tolerated both formulas and were randomized to receive either eHF (n = 34) or AAF (n = 32) for 180 days. Growth (weight, length, and head circumference) and tolerance [skin, gastro-intestinal, and respiratory tract symptoms of allergy] were evaluated after 30, 60, 90, and 180 days. There were no significant differences between the two groups in any of the growth measurements. Length and head circumference were similar to Euro-growth standards, but weight was slightly lower. Gastro-intestinal and respiratory tract symptoms of allergy were also similar in the two groups. However, whereas SCORAD scores for atopic dermatitis remained constant throughout the study in infants-fed eHF, there was a slight decrease in those fed AAF. Infants-fed eHF had significantly fewer incidents of vomiting than infants-fed AAF and a significantly higher frequency of soft stools. The new eHF is safe and well tolerated in infants diagnosed with CMPA. SN - 1399-3038 UR - https://www.unboundmedicine.com/medline/citation/18167160/Safety_and_efficacy_of_a_new_extensively_hydrolyzed_formula_for_infants_with_cow's_milk_protein_allergy_ L2 - https://doi.org/10.1111/j.1399-3038.2007.00653.x DB - PRIME DP - Unbound Medicine ER -