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Clinical & Experimental Allergy

Treatment and secondary prevention effects of the probiotics Lactobacillus paracasei or Bifidobacterium lactis on early infant eczema: randomized controlled trial with follow-up until age 3 years

Authors

  • C. Gore,

    Corresponding author
    • School of Translational Medicine, University of Manchester, NIHR Translational Research Facility in Respiratory Medicine, University Hospital of South Manchester NHS Foundation Trust, Manchester, UK
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  • A. Custovic,

    1. School of Translational Medicine, University of Manchester, NIHR Translational Research Facility in Respiratory Medicine, University Hospital of South Manchester NHS Foundation Trust, Manchester, UK
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  • G. W. Tannock,

    1. Department of Microbiology and Immunology, University of Otago, Dunedin, New Zealand
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  • K. Munro,

    1. Department of Microbiology and Immunology, University of Otago, Dunedin, New Zealand
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  • G. Kerry,

    1. School of Translational Medicine, University of Manchester, NIHR Translational Research Facility in Respiratory Medicine, University Hospital of South Manchester NHS Foundation Trust, Manchester, UK
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  • K. Johnson,

    1. School of Translational Medicine, University of Manchester, NIHR Translational Research Facility in Respiratory Medicine, University Hospital of South Manchester NHS Foundation Trust, Manchester, UK
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  • C. Peterson,

    1. Department of Clinical Chemistry and Pharmacology, University Hospital Uppsala, Uppsala, Sweden
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  • J. Morris,

    1. School of Translational Medicine, University of Manchester, NIHR Translational Research Facility in Respiratory Medicine, University Hospital of South Manchester NHS Foundation Trust, Manchester, UK
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  • C. Chaloner,

    1. Department of Clinical Biochemistry, Royal Manchester Children's Hospital Oxford Road, Manchester, UK
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  • C. S. Murray,

    1. School of Translational Medicine, University of Manchester, NIHR Translational Research Facility in Respiratory Medicine, University Hospital of South Manchester NHS Foundation Trust, Manchester, UK
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  • A. Woodcock

    1. School of Translational Medicine, University of Manchester, NIHR Translational Research Facility in Respiratory Medicine, University Hospital of South Manchester NHS Foundation Trust, Manchester, UK
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Correspondence:

Claudia Gore, Department of Paediatric Allergy, Imperial College Healthcare NHS Trust, St Mary's Hospital, Praed St, London W2 1NY, UK

E-mail: cgore@nhs.net

Summary

Background

Allergic disease has been associated with altered intestinal microbiota. Therefore, probiotics have been suggested as a potential treatment for eczema.

Objective

We investigated whether dietary supplementation of infants with eczema at age 3–6 months with Lactobacillus paracaseiCNCM I-2116 or Bifidobacterium lactisCNCM I-3446 had a treatment effect or altered allergic disease progression.

Methods

Primary outcome included eczema severity (SCORing Atopic Dermatitis, SCORAD) 3 months post-randomization. Secondary: SCORAD (other visits); infant dermatitis quality of life (IDQoL); gastrointestinal permeability; urinary eosinophilic protein X; allergen-sensitization; allergic symptoms (age 12, 18, 36 months). A total of 208 infants aged 3–6 months with physician-diagnosed eczema were recruited; 137/208 (SCORAD≥10, consuming ≥200 mL standard formula/day) were randomized to daily supplements containing L. paracasei or B. lactis or placebo for a 3-month period, while receiving extensively hydrolysed whey-formula (dairy-free diet). There were two open observational groups, one group exclusively breastfed (n = 22) and the other, standard formula-fed (n = 49). Trial number: ISRCTN41490500.

Results

Eczema severity decreased significantly over time in all groups. No significant difference was observed between randomized groups after 12-week treatment-period (SCORAD-score pre-/post-intervention: B. lactis 25.9 [95% CI: 22.8–29.2] to 12.8 [9.4–16.6]; L. paracasei 25.4 [22.1–29] to 12.5 [9.2–16.4]; placebo 26.9 [23.4–30.6] to 11.8 [9.6–14.3]; P = 0.7). Results were similar when analysis was controlled for allergen-sensitization, or when only sensitized infants were analysed. No differences were found for secondary outcomes. No difference was observed in SCORAD-score between randomized and observational groups.

Conclusion and Clinical Relevance

We found no benefit from supplementation with B. lactis or L. paracasei in the treatment of eczema, when given as an adjunct to basic topical treatment, and no effect on the progression of allergic disease from age 1 to 3 years.

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