PURPOSE OF THE STUDY.
To determine whether the supplementation of prebiotics and immunoactive oligosaccharides can prevent the development of atopic dermatitis in infants.
Term weaned infants younger than 8 weeks without a family history of atopy in a parent or sibling were recruited from several northern European study centers.
This was a double-blind, placebo-controlled, randomized, prospective study. Infants were randomly assigned to the prebiotics group (PG), control group (CG), or exclusively breastfed group (BG). Infants in the PG received a nonhydrolyzed cow's milk–based formula with a specific mixture of short- and long-chain oligosaccharides (ratio 9:1, 85% of mixture) and pectin-derived acidic oligosaccharides (15% of mixture). The PG and CG received a starter formula for the first 6 months of life, and then a follow-on formula was offered. Parents were contacted every 2 weeks until the infants turned 1 year old, and clinical visits were conducted at 2, 4, 6, and 12 months of life.
Of 1187 infants screened, 1130 infants (95%) were recruited. The cumulative incidence of atopic dermatitis in the PG (5.7% [SE: 1.2%]) was significantly less than that in the CG (9.7% [SE: SE 1.5%]; P = .04) and similar to the lower range in the BG (7.3% [SE: SE 1.6%]). Median time to the development of atopic dermatitis was similar in the PG (15.1 weeks [range: 5.1–49 weeks]) and the CG (16.8 weeks [range: 4.4–50.3 weeks]) but longer in the BG (22.5 weeks [range: 4.4–50.3 weeks). In a Cox regression model, the rate of atopic dermatitis was 44% lower in the PG versus CG (P = .04). The disease-free survival period was greater in the PG versus that in the CG (P = .0377). The number needed to treat with prebiotic supplementation to prevent 1 case of atopic dermatitis was 25 infants. Atopic dermatitis in the PG at the age of 12 months tended to be less severe than in the CG (median SCORAD score: 8 vs 12; P = .08). T-helper 2–specific thymus and activation-regulated chemokine levels, total immunoglobulin E levels, and percentage sensitized to hen's egg or cow's milk were not significantly different in all 3 groups.
Prebiotic supplementation in low-risk infants reduced the risk of atopic dermatitis by 44% in the first year of life and might be an effective preventive measure in formula-fed infants. Severity of atopic dermatitis was not significantly affected.
These results might have far-reaching public health implications, because the study focused on preventing food allergy in infants who might not otherwise be identified by personal or family history of atopy. Prebiotics are generally considered safe and might be an alternative to hydrolysate formula or probiotics, which have shown variable results in infants at low risk. It is interesting to note that prebiotics might be less effective once disease has started and does not seem to have an effect on sensitization or other allergic diseases. The next step would be to investigate whether the benefit is transient or persistent and what mechanism might be responsible for the observed effects.
- Copyright © 2011 by the American Academy of Pediatrics