Probiotics-in-Pregnancy-Study

BMCPregnancyChildbirth.2016Jun3;16(1):133.doi:10.1186/s12884-016-0923-y.TheProbioticsinPregnancyStudy(PiPStudy):rationaleanddesignofadouble-blindrandomisedcontrolledtrialtoimprovematernalhealthduringpregnancyandpreventinfanteczemaandallergy.BarthowC1,WickensK2,StanleyT3,MitchellEA4,MaudeR5,AbelsP6,PurdieG7,MurphyR8,StoneP9,KangJ2,HoodF2,RowdenJ4,BarnesP2,FitzharrisP10,CraigJ11,SlykermanRF4,CraneJ2.Authorinformation1DepartmentofMedicine,UniversityofOtagoWellington,POBox7343,WellingtonSouth,6242,[e-mail].2DepartmentofMedicine,UniversityofOtagoWellington,POBox7343,WellingtonSouth,6242,NewZealand.3DepartmentofPaediatrics,UniversityofOtagoWellington,POBox7343,WellingtonSouth,6242,NewZealand.4DepartmentofPaediatrics:ChildandYouthHealth,UniversityofAuckland,PrivateBag92019,Auckland,1142,NewZealand.5GraduateSchoolofNursing,MidwiferyandHealth,VictoriaUniversityofWellington,POBox7625,Newtown,Wellington,6242,NewZealand.6DepartmentofObstetricsandGynaecology,UniversityofOtagoWellington,POBox7343,WellingtonSouth,6242,NewZealand.7Dean'sDepartment,UniversityofOtagoWellington,POBox7343,WellingtonSouth,6242,NewZealand.8DepartmentofMedicine,UniversityofAuckland,PrivateBag92019,Auckland,1142,NewZealand.9DepartmentofObstetricsandGynaecology,UniversityofAuckland,PrivateBag92019,Auckland,1142,NewZealand.10ImmunologyDepartment,AucklandHospital,PrivateBag92024,AucklandMailCentre,Auckland,1142,NewZealand.11MurdochChildren'sResearchInstitute,TheRoyalChildren'sHospital,FlemingtonRoad,Parkville,Melbourne,Victoria,3052,Australia.AbstractBACKGROUND:Worldwidethereisincreasinginterestinthemanipulationofhumangutmicrobiotabytheuseofprobioticsupplementstomodifyorpreventarangeofcommunicableandnon-communicablediseases.Probioticinterventionsadministeredduringpregnancyandbreastfeedingofferauniqueopportunitytoinfluencearangeofimportantmaternalandinfantoutcomes.TheaimoftheProbioticsinPregnancyStudy(PiPStudy)istoassessifsupplementationbytheprobioticLactobacillusrhamnosusHN001administeredtowomenfromearlypregnancyandwhilebreastfeedingcanreducetheratesofinfanteczemaandatopicsensitisationat1year,andmaternalgestationaldiabetesmellitus,bacterialvaginosisandGroupBStreptococcalvaginalcolonisationbeforebirth,anddepressionandanxietypostpartum.METHODS/DESIGN:ThePiPStudyisatwo-centre,randomised,double-blindplacebo-controlledtrialinWellingtonandAuckland,NewZealand.Fourhundredpregnantwomenexpectinginfantsathighriskofallergicdiseasewillbeenrolledinthestudyat14-16weeksgestationandrandomisedtoreceiveeitherLactobacillusrhamnosusHN001(6 × 10(9)colony-formingunitsperday(cfu/day))orplacebountildeliveryandthencontinuinguntil6monthspost-partum,ifbreastfeeding.Primaryinfantoutcomesarethedevelopmentandseverityofeczemaandatopicsensitisationinthefirstyearoflife.Secondaryoutcomesarediagnosisofmaternalgestationaldiabetesmellitus,presenceofbacterialvaginosisandvaginalcarriageofGroupBStreptococcus(at35-37weeksgestation).Otheroutcomemeasuresincludematernalweightgain,maternalpostpartumdepressionandanxiety,infantbirthweight,pretermbirth,andrateofcaesareansections.Arangeofsamplesincludingmaternalandinfantfaecalsamples,maternalbloodsamples,cordbloodandinfantcordtissuesamples,breastmilk,infantskinswabsandinfantbuccalswabswillbecollectedfortheinvestigationofthemechanismsofprobioticaction.DISCUSSION:Thestudywillinvestigateifmother-onlysupplementationwithLactobacillusrhamnosusHN001inpregnancyandwhilebreastfeedingcanreduceratesofeczemaandatopicsensitisationininfantsby1year,andreducematernalratesofgestationaldiabetesmellitus,bacterialvaginosis,vaginalcarriageofGroupBStreptococcusbeforebirthandmaternaldepressionandanxietypostpartum.TRIALREGISTRATION:AustralianNewZealandClinicalTrialsRegistration:ACTRN12612000196842.DateRegistered:15/02/12.