Abstract

Probiotics may have immunomodulatory effects. However, these effects in asthma remain unclear and warrant clinical trials. Here, we evaluated the effects of Lactobacillus paracasei (LP), Lactobacillus fermentum (LF), and their combination (LP + LF) on the clinical severity, immune biomarkers, and quality of life in children with asthma. This double-blind, prospective, randomized, placebo-controlled trial included 160 children with asthma aged 6–18 years (trial number: NCT01635738), randomized to receive LP, LF, LP + LF, or a placebo for 3 months. Their Global Initiative for Asthma–based asthma severity, Childhood Asthma Control Test (C-ACT) scores, Pediatric Asthma Severity Scores, Pediatric Asthma Quality of Life Questionnaire scores, peak expiratory flow rates (PEFRs), medication use, the levels of immune biomarkers (immunoglobulin E (IgE), interferon γ, interleukin 4, and tumor necrosis factor α) at different visits, and the associated changes were evaluated. Compared with the placebo group by generalized estimating equation model, children receiving LP, LF, and LP + LF had lower asthma severity (p = 0.024, 0.038, and 0.007, respectively) but higher C-ACT scores (p = 0.005, < 0.001, and < 0.001, respectively). The LP + LF group demonstrated increased PEFR (p < 0.01) and decreased IgE levels (p < 0.05). LP, LF, or their combination (LP + LF) can aid clinical improvement in children with asthma.

Highlights

  • Asthma, a chronic complex disease of the airways, is characterized by reversible airflow obstruction, bronchial hyperresponsiveness, and underlying inflammation [1]

  • The primary outcome was the changes in asthma severity and Childhood Asthma Control Test (C-ACT) scores over 3 months of the intervention compared with baseline

  • Compared with the placebo group, both asthma severity and C-ACT scores significantly improved in the Lactobacillus paracasei (LP), Lactobacillus fermentum (LF), and LP + LF groups according to our age- and sex-adjusted generalized estimating equation (GEE) model (Table 3)

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Summary

Introduction

A chronic complex disease of the airways, is characterized by reversible airflow obstruction, bronchial hyperresponsiveness, and underlying inflammation [1]. A potential mechanism underlying this high prevalence is the microbial hypothesis [2], which argues that less microbial exposure upregulates the cytokine production of T-helper cell type 2 (Th2), leading to an increase in allergic diseases According to this hypothesis, probiotic administration is an alternative treatment for atopic disease, which when administered in adequate amounts, can confer a health benefit to the host [3]. Lee et al reported significant improvements in the pulmonary function of children with asthma after a regimen of vegetable, fish oil, and fruit supplementation along with probiotic administration [6] These aforementioned studies were designed as mixed interventions with relatively small sample sizes. We focused on the therapeutic effects of the probiotics on the disease severity, quality of life, immune biomarkers, and fecal microbial composition in school-age children with asthma

Participants
Protocol
Outcome Measures
Laboratory Methods
Sample Size Estimation
Statistical Analysis
Baseline Characteristics of Participants
Effects of Probiotics on Severity of Asthma and Quality of Life
Effects of Probiotics
Immune
Findings
Conclusions
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