Mechanisms of AllergyThe effect of hydrolyzed cow's milk formula for allergy prevention in the first year of life: The German Infant Nutritional Intervention Study, a randomized double-blind trial☆,☆☆,★
Section snippets
Methods
This study is a prospective, randomized, double-blind intervention trial to assess the allergy-preventive effect of differently hydrolyzed formulas compared with CMF in infants at risk for atopy. Infants were recruited between September 1995 and June 1998 in obstetric units throughout 2 areas of Germany (Wesel, North Rhine Westphalia, and Munich, Bavaria).
Baseline characteristics
A total of 2252 infants were included in the study and randomized to the study formula (Fig 1). Within the first 4 weeks, 114 (5%) of 2252 children left the study without physical examination and information on feeding modalities. A total of 889 (42%) of 2138 mothers exclusively breast-fed their infants during the first 4 months; all but 24 (3%) of 889 could be followed-up during the entire study period. Study formula was given to 1249 infants, but 166 (13%) of 1249 dropped out
Discussion
Our results confirm that allergy prevention in the first year of life in infants with a familial risk for atopy is possible by feeding hydrolyzed formulas instead of CMF as a supplement or substitute for breast milk. AM was significantly prevented by eHF-C, whereas AD as the predominant allergic disease during infancy was prevented by eHF-C and pHF-W but not by eHF-W. For the first time, we could demonstrate that the preventive potential of the different formulas depends on the family history
Acknowledgements
We thank the families for participation in the study; the obstetric units for allowing the recruitment procedure; the GINI Study team for excellent work, especially Angela Schoetzau; and the advisory board (Ulrich Wahn, Stephan Strobel, Max Kjellman, and Willi Heine [until 1997]) for scientific support. We also thank Torsten Bauer for helping to prepare the manuscript.
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*A list of contributors and members of the GINI Study team are listed in the Appendix.
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Supported by the Federal Ministry for Education, Science, Research, and Technology (grant no. 01 EE 9401-4) and the Child Health Foundation, Munich, Germany. Nestlé, Hipp, Milupa, Numico, and Mead Johnson provided the study formulas, and SHS provided the formula for the elimination diet.
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Reprint requests: Andrea von Berg, MD, Research Institute for Prevention of Allergies and Airway Diseases, Children's Department Marien-Hospital, Pastor-Janßen-Str. 8-38, 46483 Wesel, Germany.