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

Berg, Andrea von; Filipiak-Pittroff, Birgit; Krämer, Ursula; Hoffmann, Barbara; Link, Elke; Beckmann, Christina; Hoffmann, Ute; Reinhardt, D.; Grübl, A.; Heinrich, Joachim; Wichmann, H‐Erich; Bauer, Carl-P.; Koletzko, Sibylle; Berdel, Dietrich

doi:10.1016/j.jaci.2013.01.006

Cited by 137 publications

(73 citation statements)

References 32 publications

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“…These findings contrast with some previous studies suggesting that hydrolysed formula or prebiotics alone may reduce eczema risk in formula‐fed infants 4, 5, 6, 7. We also found no effect on total or specific IgE levels, or a range of other immune markers at 6 months.…”

Section: Discussioncontrasting

confidence: 99%

“…The effect of hydrolysed infant formula intake on eczema risk is controversial, with positive findings in one large trial and negative findings in a separate large trial 7, 8. Consistent with the negative study, our data failed to demonstrate a protective effect of partially hydrolysed prebiotic‐supplemented infant formula against eczema incidence.…”

Section: Discussionsupporting

confidence: 64%

“…Intervention trials in formula‐fed infants have found reduced eczema risk when formula is supplemented with a specific oligosaccharide mix 4, 5, 6. There is inconsistent evidence that partially hydrolysed formula reduces eczema risk compared with intact cow's milk formula in high‐risk infants 7, 8, 9. However, current dietary prevention guidance includes the use of partially or extensively hydrolysed formula for infants at an increased allergic disease risk where formula is introduced before 6 months 9, 10.…”

mentioning

confidence: 99%

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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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Section: Discussioncontrasting

confidence: 99%

Section: Discussionsupporting

confidence: 64%

mentioning

confidence: 99%

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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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“…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%

“…Results appear especially consistent for eczema 20 within the first year of life. Randomized, controlled trials of nutritional interventions with hydrolyzed formulas on allergic outcomes in adolescence, including asthma, hay fever/allergic rhinitis (AR) and eczema, are scarce 21 or have used a multifaceted approach that combined nutritional and aeroallergen avoidance measures 22, 23, 24. Data on the long‐term effectiveness of these interventions are important because asthma and especially AR risk increase during adolescence.…”

mentioning

confidence: 99%

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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Infant formulas containing hydrolysed protein for prevention of allergic disease and food allergy

Osborn

Sinn

Jones

2017

Cochrane Database of Systematic Reviews

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We found no evidence to support short-term or prolonged feeding with a hydrolysed formula compared with exclusive breast feeding for prevention of allergy. Very low-quality evidence indicates that short-term use of an EHF compared with a CMF may prevent infant CMA.In infants at high risk of allergy not exclusively breast fed, very low-quality evidence suggests that prolonged hydrolysed formula feeding compared with CMF feeding reduces infant allergy and infant CMA. Studies have found no difference in childhood allergy and no difference in specific allergy, including infant and childhood asthma, eczema and rhinitis and infant food allergy.Very low-quality evidence shows that prolonged use of a partially hydrolysed formula compared with a CMF for partial or exclusive feeding was associated with a reduction in infant allergy incidence and CMA incidence, and that prolonged use of an EHF versus a PHF reduces infant food allergy.

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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

Cited by 137 publications

References 32 publications

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

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

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

Infant formulas containing hydrolysed protein for prevention of allergic disease and food allergy

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