Safety and Tolerability of Lactobacillus reuteri DSM 17938 and Effects on Biomarkers in Healthy Adults Results from a Randomized Masked Trial 英文参考文献.docVIP

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Safety and Tolerability of Lactobacillus reuteri DSM 17938 and Effects on Biomarkers in Healthy Adults Results from a Randomized Masked Trial 英文参考文献.doc

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Safety and Tolerability of Lactobacillus reuteri DSM 17938 and Effects on Biomarkers in Healthy Adults Results from a Randomized Masked Trial 英文参考文献

SafetyandTolerabilityofLactobacillusreuteriDSM 17938andEffectsonBiomarkersinHealthyAdults: ResultsfromaRandomizedMaskedTrial NishaMangalat1.,YuyingLiu1.,NicoleY.Fatheree1,MichaelJ.Ferris2,MelissaR.VanArsdall1, ZhongxueChen3,MohammadH.Rahbar3,4,WallaceA.Gleason1,JohanaNorori2,DatQ.Tran1, J.MarcRhoads1* 1Department of Pediatrics, University of Texas Medical School at Houston, Houston, Texas, United States of America, 2Department of Pediatrics, Louisiana State UniversityHealthScienceCenterandTheResearchInstituteforChildren,NewOrleans,Louisiana,UnitedStatesofAmerica,3Biostatistics/Epidemiology/ResearchDesign Core, Center for Clinical and Translational Sciences, University of Texas Health Science Center at Houston, Houston, Texas, United States of America, 4Division of Epidemiology,HumanGenetics,andEnvironmentalSciences,TheUniversityofTexasSchoolofPublicHealthatHouston,Houston,Texas,UnitedStatesofAmerica Abstract Background: There are few carefully-designed studies investigating the safety of individual probiotics approved under InvestigationalNewDrugpolicies. Objectives:Theprimaryaimofthisprospective,double-blindplacebo-controlledtrialwastoinvestigateifdailytreatment of adults with Lactobacillus reuteri DSM 17938 (LR) for 2 months is safe and well-tolerated. Our secondary aim was to determine if LR treatment has immune effects as determined by regulatory T cell percentages, expression of toll-like receptors (TLR)-2 and 24 on circulating peripheral blood mononuclear cells (PMBCs), cytokine expression by stimulated PBMC,andintestinalinflammationasmeasuredbyfecalcalprotectin. Methods: Forty healthy adults were randomized to a daily dose of 56108CFUs of LR (n=30) or placebo (n=10) for 2 months.Participantscompletedadailydiarycardandhad7clinicvisitsduringtreatmentandobservation. Results:Therewerenosevereadverseevents(SAEs)andnosignificantdifferencesinadverseevents(AEs).Therewereno differencesinPBMCsubclasses,TLRs,orcytokineexpressionaftertreatment.Theprobiotic-treatedgroup