Early Probiotic Supplementation for Eczema and Asthma Prevention: A Randomized Controlled Trial

Abstract

Objectives: To determine if probiotic administration during the first 6 months of life decreases childhood asthma and eczema.

Methods: We conducted a randomized, double-blind controlled trial of Lactobacillus rhamnosus GG (LGG) supplementation on the cumulative incidence of eczema (primary end point) and asthma and rhinitis (secondary end points) in high-risk infants. For the first 6 months of life, intervention infants (n = 92) received a daily dose of 10 billion colony-forming units of LGG and 225 mg of inulin (Amerifit Brands, Cromwell, CT), and control infants (n = 92) received 325 mg of inulin alone. We used survival analysis methods to estimate disease incidences in the presence or absence of LGG and to estimate the efficacy of LGG in delaying or preventing these diseases.

Results: Infants were accrued over a 6-year period (median follow-up: 4.6 years; 95% retention rate at 2 years). At 2 years of age, the estimated cumulative incidence of eczema was 30.9% (95% confidence interval [CI], 21.4%-40.4%) in the control arm and 28.7% (95% CI, 19.4%-38.0%) in the LGG arm, for a hazard ratio of 0.95 (95% CI, 0.59-1.53) (log-rank P = .83). At 5 years of age, the cumulative incidence of asthma was 17.4% (95% CI, 7.6%-27.1%) in the control arm and 9.7% (95% CI, 2.7%-16.6%) in the LGG arm, for a hazard ratio of 0.88 (95% CI, 0.41-1.87) (log-rank P = .25).

Conclusions: For high-risk infants, early LGG supplementation for the first 6 months of life does not appear to prevent the development of eczema or asthma at 2 years of age.

Conflict of interest statement

POTENTIAL CONFLICT OF INTEREST: Dr Lynch is a co-founder and serves on the board of directors for Siolta Therapeutics, a microbiome therapeutics company; Dr Cabana has served as a paid scientific consultant to BioGaia, Mead Johnson Nutrition, Nestlé, and Wyeth (unrelated to the current study), has received grant funding from Nestec (unrelated to the current study), and has served on the Merck Speakers Bureau for topics focused on medication adherence (unrelated to the current study); and the other authors have indicated they have no potential conflicts of interest to disclose.

Copyright © 2017 by the American Academy of Pediatrics.

Figures

FIGURE 1

Cumulative incidence of eczema by the Kaplan-Meier method. At 2 years of age, the estimated cumulative incidence of eczema was 30.9% (95% CI, 21.4%–40.4%) for the control arm and 28.7% (95% CI, 19.4–38.0%) for the LGG arm, for an HR of 0.95 (95% CI, 0.59–1.53) (log-rank P = .83).

FIGURE 2

Cumulative incidence of asthma by the Kaplan-Meier method. At 5 years of age, the cumulative incidence of asthma was 17.4% (95% CI, 7.6%–27.1%) in the control arm and 9.7% (95% CI, 2.7%–16.6%) in the LGG arm, for an HR of 0.88 (95% CI, 0.41–1.87) (log-rank P = .25).