title: Allergic manifestation 15 years after early intervention with hydrolyzed formulas--the GINI Study.
abstract: BACKGROUND
  Data on the long-term impact of hydrolyzed formulas on allergies are scarce.
  
  
  OBJECTIVE
  To assess the association between early intervention with hydrolyzed formulas in high-risk children and allergic outcomes in adolescence.
  
  
  METHODS
  GINI trial participants (n = 2252) received one of four formulas in the first four months of life as breastmilk substitute if necessary: partial or extensive whey hydrolyzate (pHF-W, eHF-W), extensive casein hydrolyzate (eHF-C) or standard cow's milk formula (CMF) as reference. Associations between these formulas and the cumulative incidence and prevalence of parent-reported physician-diagnosed asthma, allergic rhinitis (AR) and eczema, as well as spirometric indices and sensitization, were examined using generalized linear models.
  
  
  RESULTS
  Between 11 and 15 years, the prevalence of asthma was reduced in the eHF-C group compared to CMF (odds ratio (OR) 0.49, 95% confidence interval (CI) 0.26-0.89), which is consistent with the spirometric results. The cumulative incidence of AR was lower in eHF-C (risk ratio (RR) 0.77, 95% CI 0.59-0.99]) and the AR prevalence in pHF-W (OR 0.67, 95% CI 0.47-0.95) and eHF-C (OR 0.59, 95% CI 0.41-0.84). The cumulative incidence of eczema was reduced in pHF-W (RR 0.75, 95% CI 0.59-0.96) and eHF-C (RR 0.60, 95% CI 0.46-0.77), as was the eczema prevalence between 11 and 15 years in eHF-C (OR 0.42, 95% CI 0.23-0.79). No significant effects were found in the eHF-W group on any manifestation,nor was there an effect on sensitization with any formula.
  
  
  CONCLUSIONS
  In high-risk children, early intervention using different hydrolyzed formulas has variable preventative effects on asthma, allergic rhinitis and eczema up to adolescence.
authors.affiliation: Department of Pediatrics, Marien-Hospital Wesel, Research Institute, Wesel, Germany.
authors.forename: A
authors.initials: A
authors.lastname: von Berg
authors.affiliation: Department of Pediatrics, Marien-Hospital Wesel, Research Institute, Wesel, Germany.
authors.forename: B
authors.initials: B
authors.lastname: Filipiak-Pittroff
authors.affiliation: Institute of Epidemiology I, Helmholtz Zentrum Munich, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.|Comprehensive Pneumology Center Munich (CPC-M), Munich, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Schulz
authors.affiliation: Institute of Epidemiology I, Helmholtz Zentrum Munich, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.|Department of Pediatrics, Technical University of Munich, Munich, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Hoffmann
authors.affiliation: IUF - Leibniz Research Institute for Environmental Medicine at the Heinrich-Heine-University, Düsseldorf, Germany.
authors.forename: E
authors.initials: E
authors.lastname: Link
authors.affiliation: Institute of Epidemiology I, Helmholtz Zentrum Munich, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Sußmann
authors.affiliation: Institute of Epidemiology I, Helmholtz Zentrum Munich, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Schnappinger
authors.affiliation: Institute of Epidemiology I, Helmholtz Zentrum Munich, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.
authors.forename: I
authors.initials: I
authors.lastname: Brüske
authors.affiliation: Institute of Epidemiology I, Helmholtz Zentrum Munich, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Standl
authors.affiliation: IUF - Leibniz Research Institute for Environmental Medicine at the Heinrich-Heine-University, Düsseldorf, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Krämer
authors.affiliation: IUF - Leibniz Research Institute for Environmental Medicine at the Heinrich-Heine-University, Düsseldorf, Germany.|Medical Faculty, Deanery of Medicine, Heinrich-Heine University, Düsseldorf, Germany.
authors.forename: B
authors.initials: B
authors.lastname: Hoffmann
authors.affiliation: Institute of Epidemiology I, Helmholtz Zentrum Munich, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.|Comprehensive Pneumology Center Munich (CPC-M), Munich, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Heinrich
authors.affiliation: Department of Pediatrics, Technical University of Munich, Munich, Germany.|LVA Oberbayern, Munich, Germany.
authors.forename: C-P
authors.initials: CP
authors.lastname: Bauer
authors.affiliation: Dr von Hauner Children's Hospital, Ludwig-Maximilians-University, University of Munich Medical Center, Munich, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Koletzko
authors.affiliation: Department of Pediatrics, Marien-Hospital Wesel, Research Institute, Wesel, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Berdel
mesh_terms: D000293:Adolescent; D000818:Animals; D002417:Cattle; D002648:Child; D002675:Child, Preschool; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006967:Hypersensitivity / Q000175:diagnosis / Q000453:epidemiology* / Q000209:etiology / Q000517:prevention & control*; D015994:Incidence; D007223:Infant; D041943:Infant Formula; D007231:Infant, Newborn; D008297:Male; D008892:Milk; D008894:Milk Proteins; D016017:Odds Ratio; D063868:Patient Outcome Assessment; D015995:Prevalence; D013147:Spirometry
chemical_list: D008894:Milk Proteins
keywords: 15-year follow-up from birth; allergy prevention; double-blind; hydrolyzed infant formulas; nutritional intervention; randomized trial