Dataset Information

Efficacy of Lactobacillus Administration in School-Age Children with Asthma: A Randomized, Placebo-Controlled Trial.

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 ?, interleukin 4, and tumor necrosis factor ?) 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.

SUBMITTER: Huang CF

PROVIDER: S-EPMC6265750 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Efficacy of Lactobacillus Administration in School-Age Children with Asthma: A Randomized, Placebo-Controlled Trial.

Huang Chian-Feng CF Chie Wei-Chu WC Wang I-Jen IJ

Nutrients 20181105 11

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), ...[more]

PMID: 30400588

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Project description:Abstract In this clinical trial, the safety and effectiveness of Lactobacillus paracasei N1115 (LP N1115) were investigated as a potential probiotic to enhance gut development in young children born by caesarean section. Infants and young children between the ages of 6 months and 3 years were administered with a probiotic consisting of LP N1115 strain (n = 30) or placebo supplement (n = 30) over an 8 weeks intervention. And the stool consistency, bowel habits, salivary cortisol, fecal microbiota, and short‐chain fatty acid metabolism were investigated. Efficacy data were obtained from 58 participants who completed the study. Overall, the placebo functioned similarly to LP N1115 group in relation to stool consistency, gastrointestinal symptoms, salivary cortisol, and short‐chain fatty acids. However, the scoring data relating to the 6–18 months subgroup receiving LP N1115 remained stable over 8 weeks in comparison to placebo. Analysis of the fecal microbiota using 16S rRNA amplicon sequencing revealed that the phyla Firmicutes represented 62% of the microbial relative abundance in the feces of the subjects during the intervening period. No significant changes in alpha‐ or beta‐diversity were noted between the placebo and LP N1115 groups overtime and at each time point. Differential abundance analysis indicated an increase in Lactobacillus in LP N1115 group at weeks 4 (p < .05) and 8 (p < .05) in comparison to the placebo group. These results suggest that probiotic supplementation with LP N1115 was well tolerated by the young children and subtle changes in the microbiome were noted throughout the intervention period. A randomized, double‐blind, parallel, placebo‐controlled study on Lactobacillus paracasei N1115 (LP N1115) was investigated as a probiotic to enhance gut development in young children born by caesarean section. Infants and young children between the ages of 6 months and 3 years were administered with a probiotic consisting of LP N1115 strain (n = 30) or placebo supplement (n = 30) over an 8 weeks intervention. The study results would seem to indicate that efficacy of LP N1115 supplementation at an early age may be effective in enhancing the gut development.

Project description:ObjectiveTo evaluate the impact of the School-Based Asthma Therapy trial on asthma symptoms among urban children with persistent asthma.DesignRandomized trial, with children stratified by smoke exposure in the home and randomized to a school-based care group or a usual care control group.SettingRochester, New York.ParticipantsChildren aged 3 to 10 years with persistent asthma.InterventionsDirectly observed administration of daily preventive asthma medications by school nurses (with dose adjustments according to National Heart, Lung, and Blood Institute Expert Panel guidelines) and a home-based environmental tobacco smoke reduction program for smoke-exposed children, using motivational interviewing.Main outcome measureMean number of symptom-free days per 2 weeks during the peak winter season (November-February), assessed by blinded interviews.ResultsWe enrolled 530 children (74% participation rate). During the peak winter season, children receiving preventive medications through school had significantly more symptom-free days compared with children in the control group (adjusted difference = 0.92 days per 2 weeks; 95% confidence interval, 0.50-1.33) and also had fewer nighttime symptoms, less rescue medication use, and fewer days with limited activity (all P < .01). Children in the treatment group also were less likely than those in the control group to have an exacerbation requiring treatment with prednisone (12% vs 18%, respectively; relative risk = 0.64; 95% confidence interval, 0.41-1.00). Stratified analyses showed positive intervention effects even for children with smoke exposure (n = 285; mean symptom-free days per 2 weeks: 11.6 for children in the treatment group vs 10.9 for those in the control group; difference = 0.96 days per 2 weeks; 95% confidence interval, 0.39-1.52).ConclusionsThe School-Based Asthma Therapy intervention significantly improved symptoms among urban children with persistent asthma. This program could serve as a model for improved asthma care in urban communities.

Dataset Information

Efficacy of Lactobacillus Administration in School-Age Children with Asthma: A Randomized, Placebo-Controlled Trial.

Publications

Efficacy of <i>Lactobacillus</i> Administration in School-Age Children with Asthma: A Randomized, Placebo-Controlled Trial.

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