Probiotics to improve outcomes of colic in the community Protocol for the Baby Biotics randomised controlled trial 英文参考文献.docVIP

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Probiotics to improve outcomes of colic in the community Protocol for the Baby Biotics randomised controlled trial 英文参考文献.doc

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Probiotics to improve outcomes of colic in the community Protocol for the Baby Biotics randomised controlled trial 英文参考文献

Sungetal.BMCPediatrics2012,12:135 /1471-2431/12/135 STUDY PROTOCOL OpenAccess Probioticstoimproveoutcomesofcolicinthe community:ProtocolfortheBabyBiotics randomisedcontrolledtrial ValerieSung1,2,3*,HarrietHiscock1,2,3,MimiTang2,3,4,FionaKMensah2,3,5,RalfGHeine2,3,4,6,AmandaStock7, ElissaYork1,2,RonaldGBarr8andMelissaWake1,2,3 Abstract Background:Infantcolic,characterisedbyexcessivecrying/fussingfornoapparentcause,affectsupto20%of infantsunderthreemonthsofageandisagreatburdentofamilies,healthprofessionalsandthehealthsystem. Onepromisingapproachtoimprovingitsmanagementistheuseoforalprobiotics.TheBabyBioticstrialaimsto determinewhethertheprobioticLactobacillusreuteriDSM17938iseffectiveinreducingcryingininfantslessthan threemonthsold(13.0weeks)withinfantcolicwhencomparedtoplacebo. Methods/Design:Design:Double-blind,placebo-controlledrandomisedtrialinMelbourne,Australia.Participants: 160breastandformulafedinfantslessthanthreemonthsoldwhopresenteithertoclinicalorcommunityservices andmeetWessel’scriteriaofcryingand/orfussing.Intervention:Oralonce-dailyLactobacillusreuteri(1x108cfu) versusplaceboforonemonth.Primaryoutcome:Infantcrying/fussingtimeper24hoursatonemonth.Secondary outcomes:i)numberofepisodesofinfantcrying/fussingper24hoursandii)infantsleepdurationper24hours(at 7,14,21,28daysand6months);iii)maternalmentalhealthscores,iv)familyfunctioningscores,v)parentquality adjustedlifeyearsscores,andvi)interventioncost-effectiveness(atoneandsixmonths);andvii)infantfaecal microbiotadiversity,viii)infantfaecalcalprotectinlevelsandix)Eschericiacoliload(atonemonthonly).Analysis: Primaryandsecondaryoutcomesfortheinterventionversuscontrolgroupswillbecomparedwithttestsandnon- parametrictestsforcontinuousdataandchisquaredtestsfordichotomousdata.Regressionmodelswillbeusedto adjustforpotentialconfoundingfactors.Intention-to-treatanalysiswillbeapplied. Discussion:Aneffective,practicalandacceptableinterventionforinfantcolicwouldrepresentamajorclinical advance.Becauseourtrialincludesbrea