Allergies in high-risk schoolchildren after early intervention with cow's milk protein hydrolysates: 10-year results from the German Infant Nutritional Intervention (GINI) study - 30/05/13
, Birgit Filipiak-Pittroff, MSc a, b, Ursula Krämer, PhD c, Barbara Hoffmann, MD c, d, Elke Link c, Christina Beckmann, MD a, Ute Hoffmann, MD e, f, Dietrich Reinhardt, MD b, Armin Grübl, MD f, Joachim Heinrich, PhD e, H.-Erich Wichmann, MD, PhD e, g, Carl-P. Bauer, MD f, Sibylle Koletzko, MD b, Dietrich Berdel, MD aGINIplus study group∗
Abstract |
Background |
The long-term effect of nutritional intervention with hydrolysate infant formulas on allergic manifestations in high-risk children is uncertain.
Objective |
We sought to investigate the effect of hydrolysate infant formulas on allergic phenotypes in children with family history of allergies at school age.
Methods |
We analyzed data from participants of the prospective German Infant Nutritional Intervention study after 10 years of follow-up. At birth, children were randomly assigned to receive, for the first 4 months, one of 4 blinded formulas as breast milk substitute, if necessary: partially hydrolyzed whey formula (pHF-W), extensively hydrolyzed whey formula (eHF-W), extensively hydrolyzed casein formula (eHF-C), or standard cow's milk formula. Outcomes were parent-reported, physician-diagnosed allergic diseases. Log-binomial regression models were used for statistical analysis.
Results |
The relative risk for the cumulative incidence of any allergic disease in the intention-to-treat analysis (n = 2252) was 0.87 (95% CI, 0.77-0.99) for pHF-W, 0.94 (95% CI, 0.83-1.07) for eHF-W, and 0.83 (95% CI, 0.72-0.95) for eHF-C compared with standard cow's milk formula. The corresponding figures for atopic eczema/dermatits (AD) were 0.82 (95% CI, 0.68-1.00), 0.91 (95% CI, 0.76-1.10), and 0.72 (95% CI, 0.58-0.88), respectively. In the per-protocol analysis (n = 988) effects were stronger. The period prevalence of AD at 7 to 10 years was significantly reduced with eHF-C in this analysis, but there was no preventive effect on asthma or allergic rhinitis.
Conclusion |
The significant preventive effect on the cumulative incidence of allergic diseases, particularly AD, with pHF-W and eHF-C persisted until 10 years without rebound, whereas eHF-W showed no significant risk reduction. There is insufficient evidence of ongoing preventive activity at 7 to 10 years of age.
Le texte complet de cet article est disponible en PDF.Key words : Birth cohort, double-blind randomized trial, nutritional intervention, cow's milk protein hydrolysate infant formulas, long-term allergy prevention
Abbreviations used : AD, AM, aRR, CMF, CMPHIF, eHF-C, eHF-W, GEE, GINI, ISAAC, ITT, mITT, NNT, pHF-W, PP, RR
Plan
| The German Infant Nutritional Intervention (GINI) study was funded for 3 years by grants from the Federal Ministry for Education, Science, Research and Technology (grant no. 01 EE 9401-4). Milupa, Nestlé, Mead Johnson, and Nutricia provided the blinded study formulas for the participating children for the first 4 to 6 months. The 3, 6 and 10-year follow-up examinations of the GINI study were covered from the respective budgets of the initial 4 study centers (Wesel, LMU Munich, TU Munich, and Helmholtz Zentrum Munich [former GSF]), and from 6 years onward, was additionally partly funded by the Federal Ministry for Environment (IUF, FKZ 20462296). Some projects not directly related to the intervention effect of the hydrolysates (eg, effect of cesarean section, and effect of solid food introduction) were partly supported by Nestlé, Mead Johnson, Numico, Pharmacia, and Stiftung Kindergesundheit in cooperation with European Studies (eg, Enrieco). |
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| Disclosure of potential conflict of interest: A. von Berg has received speakers' fees from Nestlé, Mead Johnson, Aerocrine, AstraZeneca, Novartis, and was on the Board and has received travel support from Airsonett. The Research Institute at the Marien-Hospital has received honoraria from the industry for the performance of studies (Airsonett, Aerocrine, ALK-Abelló, Astellas, Allergopharma, AstraZeneca, Boehringer, GlaxoSmithKline, Grasax, Leti, MSD, Nestlé, Ndd, Novartis, Stallergenes), and has received research support from Deutsche Atemwegsliga, Gesellschaft für Pädiatrische Allergologie, and the Lions Club. U. Krämer has received research support from the Federal Ministry of the Environment and the German Science Foundation (DFG). J. Heinrich has received research support from the European Union and the Germany Ministry of Education and Research. C.-P. Bauer has received speakers' fees from Nestlé. S. Koletzko has received research support from Phadia, Mead Johnson, and Nestlé; has received speakers' fees from Euroimmune, MSD, Danone, Nestlé, and Hipp; and is on the advisory board for Danone, Nestlé, and Mead Johnson. D. Berdel has received reimbursement for travel expenses to GINI meetings from his institute. The rest of the authors declare that they have no relevant conflicts of interest. |
Vol 131 - N° 6
P. 1565 - juin 2013 Retour au numéro
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