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Probiotics in primary prevention of atopic disease: a randomised placebo-controlled trial, The Lancet, Volume 357, Issue 9262, 7 April 2001, Pages 1076-1079

Marko Kalliomäki, a, Seppo Salminenb, Heikki Arvilommid, Pentti Keroa, Pertti Koskinenc and Erika Isolauria

a Department of Paediatrics, Turku University Hospital, PO Box 52, FI-20521 Turku, Finland
b Department of Biochemistry and Food Chemistry, University of Turku, Turku, Finland
c Department of Clinical Chemistry, University of Turku, Turku, Finland
d National Public Health Institute, Turku, Finland

Abstract
Background Reversal of the progressive increase in frequency of atopic disease would be an important breakthrough for health care and wellbeing in Western societies. In the hygiene hypothesis this increase is attributed to reduced microbial exposure in early life. Probiotics are cultures of potentially beneficial bacteria of the healthy gut microflora. We assessed the effect on atopic disease of Lactobacillus GG (which is safe at an early age and effective in treatment of allergic inflammation and food allergy).

Methods In a double-blind, randomised placebo-controlled trial we gave Lactobacillus GG prenatally to mothers who had at least one first-degree relative (or partner) with atopic eczema, allergic rhinitis, or asthma, and postnatally for 6 months to their infants. Chronic recurring atopic eczema, which is the main sign of atopic disease in the first years of life, was the primary endpoint.

Findings Atopic eczema was diagnosed in 46 of 132 (35%) children aged 2 years. Asthma was diagnosed in six of these children and allergic rhinitis in one. The frequency of atopic eczema in the probiotic group was half that of the placebo group (15/64 [23%] vs 31/68 [46%]; relative risk 0¡¤51 [95% CI 0¡¤32–0¡¤84]). The number needed to treat was 4¡¤5 (95% CI 2¡¤6–15¡¤6).

Interpretations Lactobacillus GG was effective in prevention of early atopic disease in children at high risk. Thus, gut microflora might be a hitherto unexplored source of natural immunomodulators and probiotics, for prevention of atopic disease.

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