The 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

Berg, Andrea von; Koletzko, Sibylle; Grübl, A.; Filipiak-Pittroff, Birgit; Wichmann, H‐Erich; Bauer, Carl Peter; Reinhardt, D.; Berdel, Dietrich

doi:10.1067/mai.2003.101

Cited by 373 publications

(216 citation statements)

References 23 publications

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“…There is hardly any effect on any allergic outcomes in the eHF‐W formula group, which is consistent with previous reports from the GINI cohort 21, 25.…”

Section: Discussionsupporting

confidence: 92%

“…The design of the study, details of recruitment, randomization, blinding and allocation of the formulas, outcome definitions, and results from the one‐, three‐, six‐, and ten‐year follow‐ups have been published previously 21, 25, 26, 27, 28. In brief, between September 1995 and July 1998, a total of 2252 healthy term newborns at high risk of allergy were recruited in two regions in Germany (Wesel, Munich) and randomly allocated at birth to one of four blinded study formulas using a computer‐generated list.…”

Section: Methodsmentioning

confidence: 99%

“…High risk was defined as having at least one parent or biologic sibling with a history of allergic disease. These formulas were used during the first four months of life as a milk substitute only if exclusive breastfeeding was not possible 25.…”

Section: Methodsmentioning

confidence: 99%

“…Data on the long‐term effectiveness of these interventions are important because asthma and especially AR risk increase during adolescence. The German Infant Nutritional Intervention (GINI) study allows a longitudinal evaluation of the long‐term impact of hydrolyzed formulas on allergic outcomes in 2252 children with a positive family history for allergic diseases, which were randomized at birth to three different hydrolyzed formulas or standard cow′s milk formula 25, 26, 27, 28.…”

mentioning

confidence: 99%

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Allergic manifestation 15 years after early intervention with hydrolyzed formulas – theGINIStudy

Berg

Filipiak-Pittroff

Schulz

et al. 2015

Allergy

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BackgroundData on the long‐term impact of hydrolyzed formulas on allergies are scarce.ObjectiveTo 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.ResultsBetween 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.ConclusionIn high‐risk children, early intervention using different hydrolyzed formulas has variable preventative effects on asthma, allergic rhinitis and eczema up to adolescence.

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“…There is hardly any effect on any allergic outcomes in the eHF‐W formula group, which is consistent with previous reports from the GINI cohort 21, 25.…”

Section: Discussionsupporting

confidence: 92%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

mentioning

confidence: 99%

See 2 more Smart Citations

Allergic manifestation 15 years after early intervention with hydrolyzed formulas – theGINIStudy

Berg

Filipiak-Pittroff

Schulz

et al. 2015

Allergy

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“…Sample size: a reduction in cumulative incidence of eczema from 30% to 20% at 12 months was considered clinically relevant 17, 18, 19. Assuming 15% dropout, this study required 350 infants randomized before 4 weeks in each arm, to have 80% power to detect this reduction in eczema, using two‐tailed chi‐squared test at a significance of 0.05.…”

Section: Methodsmentioning

confidence: 99%

Prebiotic‐supplemented partially hydrolysed cow's milk formula for the prevention of eczema in high‐risk infants: a randomized controlled trial

Boyle

Tang

Chiang

et al. 2016

Allergy

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BackgroundPrevention guidelines for infants at high risk of allergic disease recommend hydrolysed formula if formula is introduced before 6 months, but evidence is mixed. Adding specific oligosaccharides may improve outcomes.ObjectiveTo evaluate whether partially hydrolysed whey formula containing oligosaccharides (0.8 g/100 ml) (pHF‐OS) can prevent eczema in high‐risk infants [ISRCTN65195597].MethodsWe conducted a parallel‐group, multicentre, randomized double‐blind controlled trial of pHF‐OS vs standard cow's milk formula. Infants with a family history of allergic disease were randomized (stratified by centre/maternal allergy) to active (n = 432) or control (n = 431) formula until 6 months of age if formula was introduced before 18 weeks. Primary outcome was cumulative incidence of eczema by 12 months in infants randomized at 0–4 weeks (375 pHF‐OS, 383 control). Secondary outcomes were cumulative incidence of eczema by 12 or 18 months in all infants randomized, immune markers at 6 months and adverse events.ResultsEczema occurred by 12 months in 84/293 (28.7%) infants allocated to pHF‐OS at 0‐4 weeks of age, vs 93/324 (28.7%) control (OR 0.98 95% CI 0.68, 1.40; P = 0.90), and 107/347 (30.8%) pHF‐OS vs 112/370 (30.3%) control in all infants randomized (OR 0.99 95% CI 0.71, 1.37; P = 0.94). pHF‐OS did not change most immune markers including total/specific IgE; however, pHF‐OS reduced cow's milk‐specific IgG1 (P < 0.0001) and increased regulatory T‐cell and plasmacytoid dendritic cell percentages. There was no group difference in adverse events.ConclusionpHF‐OS does not prevent eczema in the first year in high‐risk infants. The immunological changes found require confirmation in a separate cohort.

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A Systematic Review of the Role of Hydrolyzed Infant Formulas in Allergy Prevention

Hays

Wood²

2005

Arch Pediatr Adolesc Med

115

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The 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

Cited by 373 publications

References 23 publications

Allergic manifestation 15 years after early intervention with hydrolyzed formulas – theGINIStudy

Allergic manifestation 15 years after early intervention with hydrolyzed formulas – theGINIStudy

Prebiotic‐supplemented partially hydrolysed cow's milk formula for the prevention of eczema in high‐risk infants: a randomized controlled trial

A Systematic Review of the Role of Hydrolyzed Infant Formulas in Allergy Prevention

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