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Randomized Controlled Trial
. 2017 Sep;140(3):e20163000.
doi: 10.1542/peds.2016-3000. Epub 2017 Aug 7.

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

Michael D Cabana  1   2   3 , Michelle McKean  4 , Aaron B Caughey  5 , Lawrence Fong  6 , Susan Lynch  6 , Angela Wong  7 , Russell Leong  8 , Homer A Boushey  6 , Joan F Hilton  2
Affiliations
Randomized Controlled Trial

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

Michael D Cabana et al. Pediatrics. 2017 Sep.

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.

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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.

Figures

FIGURE 1
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
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).
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References

    1. Hill C, Guarner F, Reid G, et al. . Expert consensus document: The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotic. Nat Rev Gastroentrol Hepatol. 2014;11(8):506–514 - PubMed
    1. Noverr MC, Huffnagle GB. The ‘microflora hypothesis’ of allergic diseases. Clin Exp Allergy. 2005;35(12):1511–1520 - PubMed
    1. Kalliomäki M, Salminen S, Arvilommi H, Kero P, Koskinen P, Isolauri E. Probiotics in primary prevention of atopic disease: a randomised placebo-controlled trial. Lancet. 2001;357(9262):1076–1079 - PubMed
    1. Kalliomäki M, Salminen S, Poussa T, Arvilommi H, Isolauri E. Probiotics and prevention of atopic disease: 4-year follow-up of a randomised placebo-controlled trial. Lancet. 2003;361(9372):1869–1871 - PubMed
    1. Kalliomäki M, Salminen S, Poussa T, Isolauri E. Probiotics during the first 7 years of life: a cumulative risk reduction of eczema in a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2007;119(4):1019–1021 - PubMed

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