Clinical trial of a probiotic and herbal supplement for lung health

IntroductionDysbiosis of the gut microbiome may augment lung disease via the gut-lung axis. Proteobacteria may contribute to tissue proteolysis followed by neutrophil recruitment, lung tissue injury, and perpetuation of chronic inflammation. To study the effects of probiotics across the gut-lung axi...

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Main Authors: Nancy M. Wenger, Luhua Qiao, Teodora Nicola, Zoha Nizami, Isaac Martin, Brian A. Halloran, Kosuke Tanaka, Michael Evans, Xin Xu, Timothy G. Dinan, Charles Kakilla, Gillian DunnGalvin, Namasivayam Ambalavanan, Kent A. Willis, Amit Gaggar, Charitharth Vivek Lal
Format: Article
Language:English
Published: Frontiers Media S.A. 2023-06-01
Series:Frontiers in Nutrition
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fnut.2023.1168582/full
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author Nancy M. Wenger
Luhua Qiao
Teodora Nicola
Zoha Nizami
Isaac Martin
Brian A. Halloran
Kosuke Tanaka
Michael Evans
Xin Xu
Xin Xu
Timothy G. Dinan
Charles Kakilla
Gillian DunnGalvin
Namasivayam Ambalavanan
Kent A. Willis
Amit Gaggar
Amit Gaggar
Charitharth Vivek Lal
author_facet Nancy M. Wenger
Luhua Qiao
Teodora Nicola
Zoha Nizami
Isaac Martin
Brian A. Halloran
Kosuke Tanaka
Michael Evans
Xin Xu
Xin Xu
Timothy G. Dinan
Charles Kakilla
Gillian DunnGalvin
Namasivayam Ambalavanan
Kent A. Willis
Amit Gaggar
Amit Gaggar
Charitharth Vivek Lal
author_sort Nancy M. Wenger
collection DOAJ
description IntroductionDysbiosis of the gut microbiome may augment lung disease via the gut-lung axis. Proteobacteria may contribute to tissue proteolysis followed by neutrophil recruitment, lung tissue injury, and perpetuation of chronic inflammation. To study the effects of probiotics across the gut-lung axis, we sought to determine if a Lactobacillus probiotic and herbal blend was safe and well-tolerated in healthy volunteers and asthmatic patients.MethodsWe conducted a 1-month randomized, open-label clinical trial in Cork, Ireland with healthy and asthmatic patients who took the blend twice a day. The primary endpoint was safety with exploratory endpoints including quality of life, lung function, gut microbiome ecology, and inflammatory biomarkers.ResultsAll subjects tolerated the blend without adverse events. Asthmatic subjects who took the blend showed significant improvements in lung function as measured by forced expiratory volume and serum short chain fatty acid levels from baseline to Week 4. The gut microbiome of asthmatic subjects differed significantly from controls, with the most prominent difference in the relative abundance of the proteobacteria Escherichia coli. Administration of the probiotic maintained overall microbial community architecture with the only significant difference being an increase in absolute abundance of the probiotic strains measured by strain-specific PCR.ConclusionThis study supports the safety and efficacy potential of a Lactobacillus probiotic plus herbal blend to act on the gut-lung axis. However, due to the lack of a control group, a longer blinded, placebo-controlled study will be warranted to confirm the efficacy improvements observed in this trial.Clinical trial registrationhttps://clinicaltrials.gov/, identifier NCT05173168.
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spelling doaj.art-d74b1c86a43c49bba760c2f43a762a1b2023-06-13T04:17:44ZengFrontiers Media S.A.Frontiers in Nutrition2296-861X2023-06-011010.3389/fnut.2023.11685821168582Clinical trial of a probiotic and herbal supplement for lung healthNancy M. Wenger0Luhua Qiao1Teodora Nicola2Zoha Nizami3Isaac Martin4Brian A. Halloran5Kosuke Tanaka6Michael Evans7Xin Xu8Xin Xu9Timothy G. Dinan10Charles Kakilla11Gillian DunnGalvin12Namasivayam Ambalavanan13Kent A. Willis14Amit Gaggar15Amit Gaggar16Charitharth Vivek Lal17Division of Neonatology, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, United StatesDivision of Neonatology, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, United StatesDivision of Neonatology, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, United StatesDivision of Neonatology, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, United StatesDivision of Neonatology, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, United StatesDivision of Neonatology, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, United StatesDivision of Neonatology, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, United StatesDivision of Neonatology, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, United StatesDivision of Pulmonary and Critical Care Medicine, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, United StatesProgram in Protease and Matrix Biology, University of Alabama at Birmingham, Birmingham, AL, United StatesAtlantia Clinical Trials, Cork, IrelandAtlantia Clinical Trials, Cork, IrelandAtlantia Clinical Trials, Cork, IrelandDivision of Neonatology, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, United StatesDivision of Neonatology, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, United StatesDivision of Pulmonary and Critical Care Medicine, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, United StatesProgram in Protease and Matrix Biology, University of Alabama at Birmingham, Birmingham, AL, United StatesDivision of Neonatology, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, United StatesIntroductionDysbiosis of the gut microbiome may augment lung disease via the gut-lung axis. Proteobacteria may contribute to tissue proteolysis followed by neutrophil recruitment, lung tissue injury, and perpetuation of chronic inflammation. To study the effects of probiotics across the gut-lung axis, we sought to determine if a Lactobacillus probiotic and herbal blend was safe and well-tolerated in healthy volunteers and asthmatic patients.MethodsWe conducted a 1-month randomized, open-label clinical trial in Cork, Ireland with healthy and asthmatic patients who took the blend twice a day. The primary endpoint was safety with exploratory endpoints including quality of life, lung function, gut microbiome ecology, and inflammatory biomarkers.ResultsAll subjects tolerated the blend without adverse events. Asthmatic subjects who took the blend showed significant improvements in lung function as measured by forced expiratory volume and serum short chain fatty acid levels from baseline to Week 4. The gut microbiome of asthmatic subjects differed significantly from controls, with the most prominent difference in the relative abundance of the proteobacteria Escherichia coli. Administration of the probiotic maintained overall microbial community architecture with the only significant difference being an increase in absolute abundance of the probiotic strains measured by strain-specific PCR.ConclusionThis study supports the safety and efficacy potential of a Lactobacillus probiotic plus herbal blend to act on the gut-lung axis. However, due to the lack of a control group, a longer blinded, placebo-controlled study will be warranted to confirm the efficacy improvements observed in this trial.Clinical trial registrationhttps://clinicaltrials.gov/, identifier NCT05173168.https://www.frontiersin.org/articles/10.3389/fnut.2023.1168582/fullmicrobiomegut-lung axisprobioticLactobacillusshort-chain fatty acidsasthma
spellingShingle Nancy M. Wenger
Luhua Qiao
Teodora Nicola
Zoha Nizami
Isaac Martin
Brian A. Halloran
Kosuke Tanaka
Michael Evans
Xin Xu
Xin Xu
Timothy G. Dinan
Charles Kakilla
Gillian DunnGalvin
Namasivayam Ambalavanan
Kent A. Willis
Amit Gaggar
Amit Gaggar
Charitharth Vivek Lal
Clinical trial of a probiotic and herbal supplement for lung health
Frontiers in Nutrition
microbiome
gut-lung axis
probiotic
Lactobacillus
short-chain fatty acids
asthma
title Clinical trial of a probiotic and herbal supplement for lung health
title_full Clinical trial of a probiotic and herbal supplement for lung health
title_fullStr Clinical trial of a probiotic and herbal supplement for lung health
title_full_unstemmed Clinical trial of a probiotic and herbal supplement for lung health
title_short Clinical trial of a probiotic and herbal supplement for lung health
title_sort clinical trial of a probiotic and herbal supplement for lung health
topic microbiome
gut-lung axis
probiotic
Lactobacillus
short-chain fatty acids
asthma
url https://www.frontiersin.org/articles/10.3389/fnut.2023.1168582/full
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