GINI Study: 10 Year Results

Editor(s): A. von Berg, B. Filipiak-Pittroff, U. Kramer, B. Hoffmann, E. Link, C. Beckmann, U. Hoffmann, D. Reinhardt, A. Grubl, J. Heinrich, H.-Erich Wichmann, C. Bauer, S. Koletzko, D. Berdel Journal Articles 2013


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, physiciandiagnosed 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 5 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 5 988) 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 eHFW showed no significant risk reduction. There is insufficient evidence of ongoing preventive activity at 7  to 10 years of age. (J Allergy Clin Immunol 2013)

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