Probiotics in Pregnant Women to Prevent Allergic Disease: A Randomized, Double-blind Trial

C.K. Dotterud; O. Storrø; R. Johnsen; T. Øien

Disclosures

The British Journal of Dermatology. 2010;163(3):616-623. 

In This Article

Abstract and Introduction

Abstract

Background Previous reports have suggested that certain probiotics given to mothers and children at risk of atopy halves the incidence of atopic dermatitis (AD) at 2 years of age.
Objectives To examine if probiotics given to pregnant women in a nonselected population could prevent atopic sensitization or allergic diseases during the child's first 2 years.
Methods In a randomized, double-blind trial of children from a nonselected maternal population (ClinicalTrials.gov identifier: NCT00159523), women received probiotic milk or placebo from 36 weeks of gestation to 3 months postnatally during breastfeeding. The probiotic milk contained Lactobacillus rhamnosus GG, L. acidophilus La-5 and Bifidobacterium animalis subsp. lactis Bb-12. Children with an itchy rash for more than 4 weeks were assessed for AD. At 2 years of age, all children were assessed for atopic sensitization, AD, asthma and allergic rhinoconjunctivitis. The intention-to-treat (ITT) analysis was enabled by multiple imputations.
Results Four hundred and fifteen pregnant women were computer randomized. At 2 years, 138 and 140 children in the probiotic and the placebo groups, respectively, were assessed. In the ITT analysis, the odds ratio (OR) for the cumulative incidence of AD was 0·51 in the probiotic group compared with the placebo [95% confidence interval (CI) 0·30–0·87; P = 0·013]. There were no significant effects on asthma (OR 0·68, 95% CI 0·26–1·80; P = 0·437) or atopic sensitization (OR 1·52, 95% CI 0·74–3·14; P = 0·254).
Conclusions Probiotics given to nonselected mothers reduced the cumulative incidence of AD, but had no effect on atopic sensitization.

Introduction

Worldwide time trends for allergic diseases such as asthma, atopic dermatitis (AD) and allergic rhinoconjunctivitis (ARC) are increasing and high.[1] The hygiene hypothesis, proposed by Strachan in 1989,[2] has been revised, and the role of microbial exposure during infancy in the development of allergic diseases has received particular scientific interest.[3] Randomized controlled trials using various probiotic species and forms of administration have shown partly conflicting results in the prevention of AD and sensitization,[4–11] but were found to be effective in a meta-analysis.[12] All studies administered the probiotics directly to all or to the majority of the children. The mechanisms for the possible preventive effects of probiotics are unclear.[13] Because of the lack of change in atopic sensitization in these studies, and because a large proportion of all cases of AD develops in 'low-risk' groups, Williams pointed out the need for a study involving children both with and without a family history of atopy.[14] Furthermore, the increase in allergic diseases has been suggested to be greatest among those without a family history of atopy.[15] If the increase were due to the loss of protective bacterial colonization in mothers and children during infancy, it is reasonable to hypothesize that administration of probiotics would prevent allergic diseases, especially in those with a less hereditary disposition. In any such study, a limited administration of probiotic supplements to mothers during pregnancy would be preferred to more extended administration to infants, and might be more feasible as a possible public health intervention to prevent allergic disease.[16]

This study aimed to investigate whether a probiotic supplement given to pregnant women during the last 4 weeks of pregnancy up until 3 months after birth would reduce the incidence of allergic disease and allergic sensitization at 2 years of age compared with a placebo, in children both with and without a family history of atopy.

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