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Prebiotic-supplemented partially hydrolysed cow's milk formula for the prevention of eczema in high-risk infants: a
R J Boyle1,2, M L-K Tang3,4,5, W C Chiang6
1Section of Paediatrics, Imperial College London, London, UK.
Insights
Partially hydrolysed whey formula with oligosaccharides (pHF-OS) did not prevent eczema in high-risk infants. This formula did not show significant benefits for infant eczema prevention in the first year.
Area of Science:
- Allergy and immunology
- Pediatric nutrition
- Dermatology
Background:
- Hydrolyzed formulas are recommended for high-risk infants, but evidence is inconsistent.
- Specific oligosaccharides may enhance the benefits of hydrolyzed formulas.
Purpose of the Study:
- To assess if partially hydrolyzed whey formula with oligosaccharides (pHF-OS) prevents eczema in high-risk infants.
- To evaluate the impact of pHF-OS on immune markers and adverse events.
Main Methods:
- A randomized double-blind controlled trial compared pHF-OS with standard cow's milk formula.
- Infants with a family history of allergy were randomized until 6 months of age.
- Eczema incidence was tracked until 12 months, with secondary outcomes including immune markers.
Main Results:
- No significant difference in eczema incidence was observed between pHF-OS and control groups by 12 months.
- pHF-OS reduced cow's milk-specific IgG1 and increased regulatory T-cell and plasmacytoid dendritic cell percentages.
- No differences in adverse events were reported between the groups.
Conclusions:
- Partially hydrolyzed whey formula with oligosaccharides does not prevent eczema in high-risk infants within the first year.
- Further research is needed to confirm the observed immunological changes in a separate cohort.
Background:
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.
Objective:
To evaluate whether partially hydrolysed whey formula containing oligosaccharides (0.8 g/100 ml) (pHF-OS) can prevent eczema in high-risk infants [ISRCTN65195597].
Methods:
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.
Results:
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.
Conclusion:
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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