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

IntroductionRespiratory, 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 Bifidobacterium longum subsp. infantis YLGB-1496 in re...

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Main Authors: Xi Zhang, Ke Chen, Hanglian Lan, Haixia Chen, Hua Chen, Ping Yang, Nianyang He, Weilian Hung, Zaozhong Zeng, Changqi Liu
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-06-01
Series:Frontiers in Nutrition
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Online Access:https://www.frontiersin.org/articles/10.3389/fnut.2025.1585504/full
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author Xi Zhang
Ke Chen
Hanglian Lan
Haixia Chen
Hua Chen
Ping Yang
Nianyang He
Weilian Hung
Zaozhong Zeng
Changqi Liu
author_facet Xi Zhang
Ke Chen
Hanglian Lan
Haixia Chen
Hua Chen
Ping Yang
Nianyang He
Weilian Hung
Zaozhong Zeng
Changqi Liu
author_sort Xi Zhang
collection DOAJ
description IntroductionRespiratory, 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 Bifidobacterium longum subsp. infantis YLGB-1496 in relation to respiratory, gastrointestinal, and allergic diseases in children.MethodsEligible healthy children were randomly assigned to either an intervention group (IG, n = 50), which received the probiotic, or a control group (CG, n = 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.ResultsThe 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), χ2 = 5.797, p = 0.016]. Per protocol (PP) analyses yielded similar results [36.2% (17/47) vs. 60.4% (29/48), χ2 = 5.59, p = 0.018]. YLGB-1496 supplementation significantly increased the relative abundance of Bifidobacterium bifidum, Bifidobacterium kashiwanohense PV2, and Bifidobacterium longum, while reducing Bacteroides thetaiotaomicron levels in the IG compared to the CG (p < 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).ConclusionDaily administration of YLGB-1496 at a dosage of 1.5 × 1010 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 registrationhttps://www.isrctn.com/ISRCTN12824613, identifier: ISRCTN12824613.
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spelling doaj-art-657f3c302aa04b91a0d8b6b721f997582025-08-20T03:38:27ZengFrontiers Media S.A.Frontiers in Nutrition2296-861X2025-06-011210.3389/fnut.2025.15855041585504Effect of Bifidobacterium longum subsp. infantis YLGB-1496 on common diseases in pediatrics: a randomized, blinded, placebo-controlled trialXi Zhang0Ke Chen1Hanglian Lan2Haixia Chen3Hua Chen4Ping Yang5Nianyang He6Weilian Hung7Zaozhong Zeng8Changqi Liu9Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, ChinaDepartment of Nutrition, Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, ChinaNational Center of Technology Innovation for Dairy, Hohhot, ChinaBaoxing Center for Disease Control and Prevention, Yaan, ChinaBaoxing Center for Disease Control and Prevention, Yaan, ChinaDepartment of Child Health Care, Xindu Maternal and Child Health Care Hospital, Chengdu, ChinaDepartment of Child Health Care, Xindu Maternal and Child Health Care Hospital, Chengdu, ChinaNational Center of Technology Innovation for Dairy, Hohhot, ChinaNational Center of Technology Innovation for Dairy, Hohhot, ChinaSchool of Exercise and Nutritional Sciences, San Diego State University, San Diego, CA, United StatesIntroductionRespiratory, 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 Bifidobacterium longum subsp. infantis YLGB-1496 in relation to respiratory, gastrointestinal, and allergic diseases in children.MethodsEligible healthy children were randomly assigned to either an intervention group (IG, n = 50), which received the probiotic, or a control group (CG, n = 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.ResultsThe 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), χ2 = 5.797, p = 0.016]. Per protocol (PP) analyses yielded similar results [36.2% (17/47) vs. 60.4% (29/48), χ2 = 5.59, p = 0.018]. YLGB-1496 supplementation significantly increased the relative abundance of Bifidobacterium bifidum, Bifidobacterium kashiwanohense PV2, and Bifidobacterium longum, while reducing Bacteroides thetaiotaomicron levels in the IG compared to the CG (p < 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).ConclusionDaily administration of YLGB-1496 at a dosage of 1.5 × 1010 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 registrationhttps://www.isrctn.com/ISRCTN12824613, identifier: ISRCTN12824613.https://www.frontiersin.org/articles/10.3389/fnut.2025.1585504/fullprobioticsshort chain fatty acidschildrengut microbiotaupper respiratory tract infection
spellingShingle Xi Zhang
Ke Chen
Hanglian Lan
Haixia Chen
Hua Chen
Ping Yang
Nianyang He
Weilian Hung
Zaozhong Zeng
Changqi Liu
Effect of Bifidobacterium longum subsp. infantis YLGB-1496 on common diseases in pediatrics: a randomized, blinded, placebo-controlled trial
Frontiers in Nutrition
probiotics
short chain fatty acids
children
gut microbiota
upper respiratory tract infection
title Effect of Bifidobacterium longum subsp. infantis YLGB-1496 on common diseases in pediatrics: a randomized, blinded, placebo-controlled trial
title_full Effect of Bifidobacterium longum subsp. infantis YLGB-1496 on common diseases in pediatrics: a randomized, blinded, placebo-controlled trial
title_fullStr Effect of Bifidobacterium longum subsp. infantis YLGB-1496 on common diseases in pediatrics: a randomized, blinded, placebo-controlled trial
title_full_unstemmed Effect of Bifidobacterium longum subsp. infantis YLGB-1496 on common diseases in pediatrics: a randomized, blinded, placebo-controlled trial
title_short Effect of Bifidobacterium longum subsp. infantis YLGB-1496 on common diseases in pediatrics: a randomized, blinded, placebo-controlled trial
title_sort effect of bifidobacterium longum subsp infantis ylgb 1496 on common diseases in pediatrics a randomized blinded placebo controlled trial
topic probiotics
short chain fatty acids
children
gut microbiota
upper respiratory tract infection
url https://www.frontiersin.org/articles/10.3389/fnut.2025.1585504/full
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