亚种YLGB - 1496对儿科常见疾病的影响：一项随机、双盲、安慰剂对照试验。

Effect of subsp. YLGB-1496 on common diseases in pediatrics: a randomized, blinded, placebo-controlled trial.

作者信息

Zhang Xi, Chen Ke, Lan Hanglian, Chen Haixia, Chen Hua, Yang Ping, He Nianyang, Hung Weilian, Zeng Zaozhong, Liu Changqi

机构信息

Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.

Department of Nutrition, Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.

出版信息

Front Nutr. 2025 Jul 1;12:1585504. doi: 10.3389/fnut.2025.1585504. eCollection 2025.

DOI:10.3389/fnut.2025.1585504

PMID:40667442

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12261461/

Abstract

INTRODUCTION

Respiratory, gastrointestinal, and allergic diseases can significantly impact both the physical and mental health of children, affecting their overall quality of life. This study aimed to evaluate the preventive effects and safety of subsp. YLGB-1496 in relation to respiratory, gastrointestinal, and allergic diseases in children.

METHODS

Eligible healthy children were randomly assigned to either an intervention group (IG, = 50), which received the probiotic, or a control group (CG, = 50), which received a placebo, for a duration of 3 months. The primary outcome was the morbidity of upper respiratory tract infections (URTIs). Gut microbiota profiles were assessed via fecal 16S rRNA sequencing. Fecal immune biomarkers, including cytokines, immunoglobulins, and short-chain fatty acids (SCFAs), were measured to evaluate immune and metabolic responses.

RESULTS

The morbidity of URTIs over the 3-month intervention and follow-up period was significantly lower in the IG than in the CG. The incidence of upper respiratory tract infections (URTIs) over the 3-month intervention and follow-up period was significantly lower in the IG than in the CG, based on intention-to-treat (ITT) analysis [34.0% (17/50) vs. 58.0% (29/50), χ = 5.797, = 0.016]. Per protocol (PP) analyses yielded similar results [36.2% (17/47) vs. 60.4% (29/48), χ = 5.59, = 0.018]. YLGB-1496 supplementation significantly increased the relative abundance of PV2, and , while reducing levels in the IG compared to the CG ( < 0.05). Additionally, YLGB-1496 reduced fecal levels of pro-inflammatory factors (IL-1β and IFNγ) levels, and increased levels of immunoglobulin (IgA, IgG, and IgM) and SCFAs (including butyric acid and total SCFAs).

CONCLUSION

Daily administration of YLGB-1496 at a dosage of 1.5 × 10 CFU for 3 months significantly reduced the episodes of cough, fever, dry stool (defined as Bristol stool scale type 1-3), and eczematous changes of the skin. It also decreased the morbidity of URTIs, bronchopneumonia, and eczema, while beneficially modulating gut microbiome composition and immune function without any adverse effects.

CLINICAL TRIAL REGISTRATION

https://www.isrctn.com/ISRCTN12824613, identifier: ISRCTN12824613.

摘要

引言

呼吸道、胃肠道和过敏性疾病会对儿童的身心健康产生重大影响，进而影响他们的整体生活质量。本研究旨在评估亚种YLGB - 1496对儿童呼吸道、胃肠道和过敏性疾病的预防效果及安全性。

方法

符合条件的健康儿童被随机分为干预组（IG，n = 50），接受益生菌治疗，或对照组（CG，n = 50），接受安慰剂治疗，为期3个月。主要结局是上呼吸道感染（URTIs）的发病率。通过粪便16S rRNA测序评估肠道微生物群谱。测量粪便免疫生物标志物，包括细胞因子、免疫球蛋白和短链脂肪酸（SCFAs），以评估免疫和代谢反应。

结果

在3个月的干预和随访期内，IG组的URTIs发病率显著低于CG组。基于意向性分析（ITT），在3个月的干预和随访期内，IG组的上呼吸道感染（URTIs）发病率显著低于CG组[34.0%（17/50）对58.0%（29/50），χ = 5.797，P = 0.016]。符合方案（PP）分析得出类似结果[36.2%（17/47）对60.4%（29/48），χ = 5.59，P = 0.018]。与CG组相比，补充YLGB - 1496显著增加了PV2和[具体菌种未明确]的相对丰度，同时降低了IG组中的[具体菌种未明确]水平（P < 0.05）。此外，YLGB - 1496降低了粪便中促炎因子（IL - 1β和IFNγ）的水平，并增加了免疫球蛋白（IgA、IgG和IgM）和SCFAs（包括丁酸和总SCFAs）的水平。