Probiotics and Prebiotics consensus statement.docx
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Probiotics and Prebiotics consensus statement.docx
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ProbioticsandPrebioticsconsensusstatement
NATUREREVIEWSGASTROENTEROLOGY&HEPATOLOGY | CONSENSUSSTATEMENTOPEN
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Expertconsensusdocument:
TheInternationalScientificAssociationforProbioticsandPrebioticsconsensusstatementonthescopeandappropriateuseofthetermprobiotic
∙ColinHill,
∙FranciscoGuarner,
∙GregorReid,
∙GlennR.Gibson,
∙DanielJ.Merenstein,
∙BrunoPot,
∙LorenzoMorelli,
∙RobertoBerniCanani,
∙HarryJ.Flint,
∙SeppoSalminen,
∙PhilipC.Calder
∙& MaryEllenSanders
∙Affiliations
∙Contributions
∙Correspondingauthor
NatureReviewsGastroenterology&Hepatology
11,
506–514
(2014)
doi:
10.1038/nrgastro.2014.66
Publishedonline
10June2014
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Abstract
∙Abstract•
∙Introduction•
∙Methods•
∙Revisitingtheterm'probiotic'•
∙Implicationsoftherecommendations•
∙Conclusions•
∙References•
∙Acknowledgements•
∙Authorinformation
AnexpertpanelwasconvenedinOctober2013bytheInternationalScientificAssociationforProbioticsandPrebiotics(ISAPP)todiscussthefieldofprobiotics.Itisnow13yearssincethedefinitionofprobioticsand12yearsafterguidelineswerepublishedforregulators,scientistsandindustrybytheFoodandAgricultureOrganizationoftheUnitedNationsandtheWHO(FAO/WHO).TheFAO/WHOdefinitionofaprobiotic—“livemicroorganismswhichwhenadministeredinadequateamountsconferahealthbenefitonthehost”—wasreinforcedasrelevantandsufficientlyaccommodatingforcurrentandanticipatedapplications.However,inconsistenciesbetweentheFAO/WHOExpertConsultationReportandtheFAO/WHOGuidelineswereclarifiedtotakeintoaccountadvancesinscienceandapplications.Amorepreciseuseoftheterm'probiotic'willbeusefultoguidecliniciansandconsumersindifferentiatingthediverseproductsonthemarket.ThisdocumentrepresentstheconclusionsoftheISAPPconsensusmeetingontheappropriateuseandscopeofthetermprobiotic.
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Introduction
∙Abstract•
∙Introduction•
∙Methods•
∙Revisitingtheterm'probiotic'•
∙Implicationsoftherecommendations•
∙Conclusions•
∙References•
∙Acknowledgements•
∙Authorinformation
In2001,anExpertConsultationofinternationalscientistsworkingonbehalfoftheFoodandAgricultureOrganizationoftheUnitedNations(FAO)andtheWHOdebatedtheemergingfieldofprobiotics.Oneoutputwasareworkingofthedefinitionofprobioticstothefollowing:
“livemicroorganismswhichwhenadministeredinadequateamountsconferahealthbenefitonthehost”.1 Sincethen,thisdefinitionhasbecomethemostwidelyadoptedandacceptedversionworldwide.In2002,anFAO/WHOWorkingGroupproducedguidelinestoassistwithinterpretationoftheoriginaldocument.2 SincetheExpertConsultationreport,PubMedhasindexed>8,000additionalresearcharticlesthatusethetermprobiotic.Thescientificandclinicalevidencehaveprogressedrapidly,ashasthedevelopmentofanumberofrobustprobioticproducts.Unfortunately,misuseofthetermprobiotichasalsobecomeamajorissue,withmanyproductsexploitingthetermwithoutmeetingtherequisitecriteria.Atthesametime,probioticproductshavereceivedthelegitimateattentionofregulatoryauthoritieswithaninterestinprotectingconsumersfrommisleadingclaims.Now,itistimelytorevisittheconceptofwhatcanbedefinedasaprobiotic,considerappropriatedefinitionsandprovideusefulguidanceforstakeholders.
TheInternationalScientificAssociationforProbioticsandPrebiotics(ISAPP)organizedameetingofclinicalandscientificexpertsonprobiotics(withspecialtiesingastroenterology,paediatrics,familymedicine,gutmicrobiota,microbiologyofprobioticbacteria,microbialgenetics,immunologyandfoodscience)heldon23October2013tore-examinetheconceptofprobiotics.ParticipantsincludedmembersoftheoriginalFAO/WHOExpertPanel,membersoftheFAO/WHOWorkingGroupandotherinternationallyrecognizedexperts.Participantsinthemeetingjointlyconsideredkeyquestionsandgeneratedandapprovedtheoutcomesherebysummarized.
WehopethatthisConsensusStatementwillprovideallprobioticstakeholders,includingconsumers,researchers,health-careprofessionals,industryandlegislators,withclearerguidelinesfordefiningandusingprobiotics,whichwebelievetobepotentiallyimportantinterventionsforimprovedhealthandwellbeing.Throughoutthispaper,weusetheterm'probioticframework'torefertoallaspectsoftheprobioticfield,including:
scientificinvestigationandclinicalresearch;regulatoryinvolvementinsafety,healthbenefitclaimsandresearch;industryactivitiesincludingproduction,marketing,productclaimsandsales;andcommunicationwiththeconsumer.Moreover,weproposeasetofbenchmarkstandardsforthedifferentiationofprobioticproductsbaseduponlevelsofscientificevidence.Panelrecommendationsarelistedin Box1.
Box1:
Consensuspanelrecommendationsforthescopeofprobiotics
•RetaintheFAO/WHOdefinition1 forprobiotics,withaminorgrammaticalcorrectionas“livemicroorganismsthat,whenadministeredinadequateamounts,conferahealthbenefitonthehost”;inconsistencesbetweentheExpertConsultation1 andtheFAO/WHOGuidelines2 wereclarified
•Includeintheframeworkfordefinitionofprobioticsmicrobialspeciesthathavebeenshowninproperlycontrolledstudiestoconferbenefitstohealth
•Anyspecificclaimbeyond“containsprobiotics”mustbefurthersubstantiated
•Keeplivecultures,traditionallyassociatedwithfermentedfoodsandforwhichthereisnoevidenceofahealthbenefit,outsidetheprobioticframework
•Keepundefined,faecalmicrobiotatransplantsoutsidetheprobioticframework
•Newcommensalsandconsortiacomprisingdefinedstrainsfromhumansamples,withadequateevidenceofsafetyandefficacy,are'probiotics'
Abbreviation:
FAO,FoodandAgricultureOrganizationoftheUnitedNations.
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Methods
∙Abstract•
∙Introduction•
∙Methods•
∙Revisitingtheterm'probiotic'•
∙Implicationsoftherecommendations•
∙Conclusions•
∙References•
∙Acknowledgements•
∙Authorinformation
ThispanelwasconceivedbytheboardofdirectorsofISAPP.ISAPPisaninternationalnonprofitcollaborationofscientistsdedicatedtoadvancingscientificexcellenceinprobioticsandprebiotics.ISAPP'sactivitiesaredeterminedbytheboardofdirectors,comprisingglobalacademicscientists.ThroughitsIndustryAdvisoryCommittee,ISAPPincorporatesindustryscientistsinitsactivitiesandraisesfunds.ISAPPstrivestobeanobjective,science-basedvoicefortheprobioticandprebioticfields.
Toprepareforthepanel,expertswereselectedfromacrossarangeofrelevantdisciplines,includingcurrentboardmembersaswellasexternalexperts.Panellistsdevelopedadiscussionoutlineandtargetquestions.Severalpanellists(C.H.,B.P.,G.R.,F.G.,M.E.S.andL.M.)deliveredbriefpresentationsthataddressedthebackgroundandcoreissuesinvolvedforeachquestion.Discussionensuedforeachissueuntilaunanimousconsensuswasachieved.Afterthemeeting,individualpanellistswrotesectionsofthesummary,whichwerecompiledintoadraftreport.Thisdocumentwascirculatedandagreedbeforesubmission.
Revisitingtheterm'probiotic'
∙Abstract•
∙Introduction•
∙Methods•
∙Revisitingtheterm'probiotic'•
∙Implicationsoftherecommendations•
∙Conclusions•
∙References•
∙Acknowledgements•
∙Authorinformation
'Probiotic'isausefulandacceptedterm.TheFAO/WHOdefinitionhasbeenwidelyadoptedandhasprovenvaluabletoresearchers,regulatorsandconsumers.OrganizationsandagenciessuchasCodex(whichcomesundertheFAO/WHOumbrella),HealthCanada,3 theWorldGastroenterologyOrganisation,4 theEuropeanFoodSafetyAuthority(EFSA)andtheInstituteofFoodTechnologists5 usetheFAO/WHOdefinitionwhenreferringtoprobiotics.Thepanelnoted,however,thatamoregrammaticallycorrectdefinitionwouldbewordedas,“livemicroorganismsthat,whenadministeredinadequateamounts,conferahealthbenefitonthehost”andsupportsuseofthiswordinggoingforward.Thisdefinitionisinclusiveofabroadrangeofmicrobesandapplications,whilstcapturingtheessenceofprobiotics(microbial,viableandbeneficialtohealth).Thedefinitiondifferentiateslivemicrobesusedasprocessingaidsorsourcesofusefulcompoundsfromthosethatareadministeredprimarilyfortheirhealthbenefits.6 Thedistinctionbetweencommensalmicroorganismsandprobioticsisalsoinferredfromthisdefinition.Althoughcommensalsinthegutareoftenthesourceofprobioticstrains,untilthesestrainsareisolated,characterizedandacrediblecasepresentedfortheirhealtheffects,theycannotbecalled'probiotics'.Inthe13yearsthathavepassedsincethedefinitionwasproposed,numerouslinesofresearchhavechallengedthelimitsoftheprobioticconcept,fromliveculturespresentinfermentedfoodstofaecalmicrobiotatransplants(FMT).Thetermhasalsobeenclearlymisused,forexample,onproductssuchasmattresses,shampoos,disinfectantsandaftershave,forwhichmaintenanceofviabilityandefficacyofthemicrobesusedarenotestablished.UseofthetermprobiotichasbeenrestrictedinsomecountriesoftheEuropeanUnionbecauseitisdeemedmisleadingtoconsumersintheabsenceofapprovedhealthclaims.7 Itisnowevidentthatdifferentinterpretationsofthetermprobioticarecreatingnotab
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