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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

Overview of attention for article published in Allergy, February 2016
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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
Published in
Allergy, February 2016
DOI 10.1111/all.12848
Pubmed ID

R. J. Boyle, M. L.‐K. Tang, W. C. Chiang, M. C. Chua, I. Ismail, A. Nauta, J. O'B. Hourihane, P. Smith, M. Gold, J. Ziegler, J. Peake, P. Quinn, R. Rao, N. Brown, A. Rijnierse, J. Garssen, J. O. Warner, Christine Axelrad, Suzan Jeffries, Yvette Donald, Heather Barham, Jenny Brown, Rita Wickenden, Teresa Barnes, Simone Taylor, Susan Smith, Natalie Thomas, Anne Goh, Wong Anng Anng, Christy Cao Yu Hua, Deirdre Daly, Sinead Lafford, Claire Cullinane, Jacques Bindels, Liandre van der Merwe, Dineke Klaassen, Sophie Swinkels, Karen Knipping


Prevention 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. To evaluate whether partially hydrolysed whey formula containing oligosaccharides (0.8 g/100 ml) (pHF-OS) can prevent eczema in high-risk infants [ISRCTN65195597]. We 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. Eczema 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. pHF-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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Geographical breakdown

Country Count As %
Unknown 126 100%

Demographic breakdown

Readers by professional status Count As %
Researcher 24 19%
Student > Bachelor 21 17%
Student > Master 10 8%
Student > Doctoral Student 8 6%
Student > Ph. D. Student 8 6%
Other 24 19%
Unknown 31 25%
Readers by discipline Count As %
Medicine and Dentistry 30 24%
Nursing and Health Professions 15 12%
Agricultural and Biological Sciences 12 10%
Biochemistry, Genetics and Molecular Biology 8 6%
Immunology and Microbiology 7 6%
Other 19 15%
Unknown 35 28%