{"id":"https://openalex.org/W2089509166","doi":"https://doi.org/10.1086/523321","title":"Probiotic Foods and Drugs: Impact of US Regulatory Status on Design of Clinical Trials","display_name":"Probiotic Foods and Drugs: Impact of US Regulatory Status on Design of Clinical Trials","publication_year":2008,"publication_date":"2008-01-08","ids":{"openalex":"https://openalex.org/W2089509166","doi":"https://doi.org/10.1086/523321","mag":"2089509166","pmid":"https://pubmed.ncbi.nlm.nih.gov/18181720"},"language":"en","primary_location":{"id":"doi:10.1086/523321","doi":"https://doi.org/10.1086/523321","is_oa":false,"landing_page_url":"https://doi.org/10.1086/523321","pdf_url":null,"source":{"id":"https://openalex.org/S72350973","display_name":"Clinical Infectious Diseases","issn_l":"1058-4838","issn":["1058-4838","1537-6591"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310311648","host_organization_name":"Oxford University Press","host_organization_lineage":["https://openalex.org/P4310311648","https://openalex.org/P4310311647"],"host_organization_lineage_names":["Oxford University Press","University of Oxford"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical Infectious Diseases","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","pubmed"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5047251735","display_name":"Patricia L. Hibberd","orcid":"https://orcid.org/0000-0002-7455-8117","observed_orcids":["https://orcid.org/0000-0002-7455-8117","https://orcid.org/0000-0001-7417-6058"]},"institutions":[{"id":"https://openalex.org/I121934306","display_name":"Tufts University","ror":"https://ror.org/05wvpxv85","country_code":"US","type":"education","lineage":["https://openalex.org/I121934306"]},{"id":"https://openalex.org/I1290900354","display_name":"Tufts Medical Center","ror":"https://ror.org/002hsbm82","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I1290900354"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Patricia\u00a0L. Hibberd","raw_affiliation_strings":["Department of Geographic Medicine and Infectious Diseases, Tufts New England Medical Center, and 2Tufts University School of Medicine, Boston, Massachusetts 02111, USA. patricia.hibberd@tufts.edu","Department of Geographic Medicine and Infectious Diseases, Tufts New England Medical Center, Boston, Massachusetts","Tufts University School of Medicine, Boston, Massachusetts"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Geographic Medicine and Infectious Diseases, Tufts New England Medical Center, and 2Tufts University School of Medicine, Boston, Massachusetts 02111, USA. patricia.hibberd@tufts.edu","institution_ids":["https://openalex.org/I121934306","https://openalex.org/I1290900354"]},{"raw_affiliation_string":"Department of Geographic Medicine and Infectious Diseases, Tufts New England Medical Center, Boston, Massachusetts","institution_ids":["https://openalex.org/I1290900354"]},{"raw_affiliation_string":"Tufts University School of Medicine, Boston, Massachusetts","institution_ids":["https://openalex.org/I121934306"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5044632429","display_name":"Lisa E. Davidson","orcid":"https://orcid.org/0000-0003-0871-334X","observed_orcids":["https://orcid.org/0000-0003-0871-334X"]},"institutions":[{"id":"https://openalex.org/I1290900354","display_name":"Tufts Medical Center","ror":"https://ror.org/002hsbm82","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I1290900354"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Lisa Davidson","raw_affiliation_strings":["Department of Geographic Medicine and Infectious Diseases, Tufts New England Medical Center, Boston, Massachusetts"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Geographic Medicine and Infectious Diseases, Tufts New England Medical Center, Boston, Massachusetts","institution_ids":["https://openalex.org/I1290900354"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":2,"corresponding_author_ids":["https://openalex.org/A5047251735"],"corresponding_institution_ids":["https://openalex.org/I121934306","https://openalex.org/I1290900354"],"apc_list":{"value":4763,"currency":"USD","value_usd":4763},"apc_paid":null,"fwci":2.7746,"has_fulltext":false,"cited_by_count":18,"citation_normalized_percentile":{"value":0.88539354,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":88,"max":97},"biblio":{"volume":"46","issue":"s2","first_page":"S137","last_page":"S140"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10141","display_name":"Probiotics and Fermented Foods","score":0.9940999746322632,"subfield":{"id":"https://openalex.org/subfields/1106","display_name":"Food Science"},"field":{"id":"https://openalex.org/fields/11","display_name":"Agricultural and Biological Sciences"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},"topics":[{"id":"https://openalex.org/T10141","display_name":"Probiotics and Fermented Foods","score":0.9940999746322632,"subfield":{"id":"https://openalex.org/subfields/1106","display_name":"Food Science"},"field":{"id":"https://openalex.org/fields/11","display_name":"Agricultural and Biological Sciences"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T10902","display_name":"Complementary and Alternative Medicine Studies","score":0.003000000026077032,"subfield":{"id":"https://openalex.org/subfields/2707","display_name":"Complementary and alternative medicine"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T13417","display_name":"Biomedical Ethics and Regulation","score":0.0006000000284984708,"subfield":{"id":"https://openalex.org/subfields/2910","display_name":"Issues, ethics and legal aspects"},"field":{"id":"https://openalex.org/fields/29","display_name":"Nursing"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/probiotics","display_name":"probiotics","score":1.0},{"id":"https://openalex.org/keywords/regulatory-status","display_name":"regulatory status","score":0.6430000066757202},{"id":"https://openalex.org/keywords/clinical-trial-design","display_name":"clinical trial design","score":0.8679999709129333},{"id":"https://openalex.org/keywords/investigational-new-drug-application","display_name":"Investigational New Drug application","score":0.8169999718666077},{"id":"https://openalex.org/keywords/health-claims","display_name":"health claims","score":0.8309999704360962},{"id":"https://openalex.org/keywords/therapeutic-claims","display_name":"therapeutic claims","score":0.9010000228881836},{"id":"https://openalex.org/keywords/probiotic-safety","display_name":"probiotic safety","score":0.5849999785423279}],"concepts":[{"id":"https://openalex.org/C3018890749","wikidata":"https://www.wikidata.org/wiki/Q204711","display_name":"Food and drug administration","level":2,"score":0.8066703677177429},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.8013066053390503},{"id":"https://openalex.org/C2780255968","wikidata":"https://www.wikidata.org/wiki/Q1816730","display_name":"Probiotic","level":3,"score":0.7948448657989502},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.6402301788330078},{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.5112588405609131},{"id":"https://openalex.org/C2779530757","wikidata":"https://www.wikidata.org/wiki/Q1207505","display_name":"Quality (philosophy)","level":2,"score":0.4901455342769623},{"id":"https://openalex.org/C3018122547","wikidata":"https://www.wikidata.org/wiki/Q5690813","display_name":"Health benefits","level":2,"score":0.4580816626548767},{"id":"https://openalex.org/C2780035454","wikidata":"https://www.wikidata.org/wiki/Q8386","display_name":"Drug","level":2,"score":0.4438275694847107},{"id":"https://openalex.org/C148482608","wikidata":"https://www.wikidata.org/wiki/Q17007018","display_name":"Clinical study design","level":3,"score":0.4328632056713104},{"id":"https://openalex.org/C150903083","wikidata":"https://www.wikidata.org/wiki/Q7108","display_name":"Biotechnology","level":1,"score":0.43045035004615784},{"id":"https://openalex.org/C2987718291","wikidata":"https://www.wikidata.org/wiki/Q2095","display_name":"Food products","level":2,"score":0.42926162481307983},{"id":"https://openalex.org/C177713679","wikidata":"https://www.wikidata.org/wiki/Q679690","display_name":"Intensive care medicine","level":1,"score":0.3855481445789337},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.219927579164505},{"id":"https://openalex.org/C556039675","wikidata":"https://www.wikidata.org/wiki/Q771035","display_name":"Traditional medicine","level":1,"score":0.14061617851257324},{"id":"https://openalex.org/C31903555","wikidata":"https://www.wikidata.org/wiki/Q1637030","display_name":"Food science","level":1,"score":0.11315888166427612},{"id":"https://openalex.org/C86803240","wikidata":"https://www.wikidata.org/wiki/Q420","display_name":"Biology","level":0,"score":0.0},{"id":"https://openalex.org/C54355233","wikidata":"https://www.wikidata.org/wiki/Q7162","display_name":"Genetics","level":1,"score":0.0},{"id":"https://openalex.org/C523546767","wikidata":"https://www.wikidata.org/wiki/Q10876","display_name":"Bacteria","level":2,"score":0.0},{"id":"https://openalex.org/C138885662","wikidata":"https://www.wikidata.org/wiki/Q5891","display_name":"Philosophy","level":0,"score":0.0},{"id":"https://openalex.org/C185592680","wikidata":"https://www.wikidata.org/wiki/Q2329","display_name":"Chemistry","level":0,"score":0.0},{"id":"https://openalex.org/C111472728","wikidata":"https://www.wikidata.org/wiki/Q9471","display_name":"Epistemology","level":1,"score":0.0},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D002986","descriptor_name":"Clinical Trials as Topic","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":true},{"descriptor_ui":"D003257","descriptor_name":"Consumer Product Safety","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D007880","descriptor_name":"Legislation, Drug","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D007881","descriptor_name":"Legislation, Food","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D011786","descriptor_name":"Quality Control","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014481","descriptor_name":"United States","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014486","descriptor_name":"United States Food and Drug Administration","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D019587","descriptor_name":"Dietary Supplements","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D019936","descriptor_name":"Probiotics","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":true},{"descriptor_ui":"D019936","descriptor_name":"Probiotics","qualifier_ui":"Q000627","qualifier_name":"therapeutic use","is_major_topic":false},{"descriptor_ui":"D033161","descriptor_name":"Government Regulation","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D058870","descriptor_name":"Food, Organic","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":true}],"locations_count":3,"locations":[{"id":"doi:10.1086/523321","doi":"https://doi.org/10.1086/523321","is_oa":false,"landing_page_url":"https://doi.org/10.1086/523321","pdf_url":null,"source":{"id":"https://openalex.org/S72350973","display_name":"Clinical Infectious Diseases","issn_l":"1058-4838","issn":["1058-4838","1537-6591"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310311648","host_organization_name":"Oxford University Press","host_organization_lineage":["https://openalex.org/P4310311648","https://openalex.org/P4310311647"],"host_organization_lineage_names":["Oxford University Press","University of Oxford"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical Infectious Diseases","raw_type":"journal-article"},{"id":"pmid:18181720","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/18181720","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical infectious diseases : an official publication of the Infectious Diseases Society of America","raw_type":"Journal Article"},{"id":"pmh:oai:CiteSeerX.psu:10.1.1.840.9341","doi":null,"is_oa":false,"landing_page_url":"http://citeseerx.ist.psu.edu/viewdoc/summary?doi=10.1.1.840.9341","pdf_url":null,"source":null,"license":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"http://cid.oxfordjournals.org/content/46/Supplement_2/S137.full.pdf","raw_type":"text"}],"best_oa_location":null,"sustainable_development_goals":[{"display_name":"Good health and well-being","score":0.8371999859809875,"id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[{"id":"https://openalex.org/G2446941754","display_name":"Effects of Probiotics in Patients with Cystic Fibrosis","funder_award_id":"R21AT002388","funder_id":"https://openalex.org/F4320337593","funder_display_name":"National Center for Complementary and Integrative Health"},{"id":"https://openalex.org/G4569129558","display_name":"Developing Probiotics as Foods and Drugs - Scientific and Regulatory Challenges","funder_award_id":"R13AT003805","funder_id":"https://openalex.org/F4320337593","funder_display_name":"National Center for Complementary and Integrative Health"},{"id":"https://openalex.org/G531373449","display_name":"Midcareer Investigator Award in Patient-Oriented Research (K24)","funder_award_id":"K24AT003683","funder_id":"https://openalex.org/F4320337593","funder_display_name":"National Center for Complementary and Integrative Health"},{"id":"https://openalex.org/G5656375457","display_name":"Probiotics to Eradicate Nasal S Aureus in ESRD Patients","funder_award_id":"R21AT002133","funder_id":"https://openalex.org/F4320337593","funder_display_name":"National Center for Complementary and Integrative Health"},{"id":"https://openalex.org/G8044420520","display_name":"Probiotics to Enhance Influenza Vaccine Immunogenicity","funder_award_id":"U01AT002952","funder_id":"https://openalex.org/F4320337593","funder_display_name":"National Center for Complementary and Integrative Health"},{"id":"https://openalex.org/G8279986926","display_name":"Probiotics to Eradicate Nasal S Aureus in ESRD Patients","funder_award_id":"U01AT002133","funder_id":"https://openalex.org/F4320337593","funder_display_name":"National Center for Complementary and Integrative Health"},{"id":"https://openalex.org/G8737073232","display_name":"Effects of Probiotics in Patients with Cystic Fibrosis","funder_award_id":"U01AT002388","funder_id":"https://openalex.org/F4320337593","funder_display_name":"National Center for Complementary and Integrative Health"}],"funders":[{"id":"https://openalex.org/F4320337593","display_name":"National Center for Complementary and Integrative Health","ror":"https://ror.org/00190t495"}],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":21,"referenced_works":["https://openalex.org/W1626154196","https://openalex.org/W1861141501","https://openalex.org/W1969272687","https://openalex.org/W1997820137","https://openalex.org/W2005441308","https://openalex.org/W2045127388","https://openalex.org/W2061453528","https://openalex.org/W2075059238","https://openalex.org/W2083089709","https://openalex.org/W2111976364","https://openalex.org/W2118266802","https://openalex.org/W2127010518","https://openalex.org/W2130255026","https://openalex.org/W2136848239","https://openalex.org/W2139759128","https://openalex.org/W2140703378","https://openalex.org/W2142960568","https://openalex.org/W2153551892","https://openalex.org/W2166603584","https://openalex.org/W2244782238","https://openalex.org/W2411722769"],"related_works":["https://openalex.org/W7106658169","https://openalex.org/W1973412581","https://openalex.org/W2130003743","https://openalex.org/W2116507268","https://openalex.org/W2103436691","https://openalex.org/W2149666423","https://openalex.org/W2117897418","https://openalex.org/W2005701295","https://openalex.org/W2019802523","https://openalex.org/W4389938247"],"abstract_inverted_index":{"Probiotics":[0],"have":[1],"been":[2],"in":[3,87,131,148],"widespread":[4],"use":[5],"since":[6],"ancient":[7],"times":[8],"and":[9,17,20,49,121,136],"are":[10,32,76,163],"increasingly":[11],"being":[12],"consumed":[13],"to":[14,18,34,53,63,71,91,104,117,145,150,155],"maintain":[15],"health":[16,64],"prevent":[19],"treat":[21],"a":[22],"wide":[23],"range":[24],"of":[25,57,95,109,123],"conditions.":[26],"In":[27],"the":[28,47,88,93,106,119,133,152],"United":[29,89],"States,":[30],"probiotics":[31,58,75],"considered":[33],"be":[35,129],"foods":[36,60],"or":[37,66],"biologics,":[38],"depending":[39],"on":[40],"their":[41],"intended":[42],"use.":[43],"This":[44],"article":[45],"addresses":[46],"similarities":[48],"differences":[50],"between":[51],"approaches":[52],"conducting":[54],"clinical":[55],"trials":[56],"as":[59,67,78],"(which":[61,69],"leads":[62,70],"claims)":[65],"biologics":[68],"therapeutic":[72,107],"claims).":[73],"Most":[74],"manufactured":[77],"foods,":[79],"which":[80,161],"makes":[81],"it":[82,114],"challenging":[83],"for":[84,140,142,160],"academic":[85],"investigators":[86],"States":[90],"meet":[92],"requirements":[94],"an":[96],"Investigational":[97],"New":[98],"Drug":[99,137],"application":[100],"that":[101],"enables":[102],"them":[103],"study":[105],"effects":[108],"these":[110],"novel":[111],"agents.":[112],"Although":[113],"is":[115],"important":[116],"ensure":[118],"safety":[120,165],"quality":[122],"probiotic":[124,146],"products,":[125,147],"there":[126,162],"also":[127],"may":[128],"value":[130],"adapting":[132],"US":[134],"Food":[135],"Administration's":[138],"Guidance":[139],"Industry":[141],"Botanical":[143],"Products":[144],"part":[149],"allow":[151],"research":[153],"agenda":[154],"move":[156],"forward":[157],"with":[158],"products":[159],"no":[164],"concerns.":[166]},"counts_by_year":[{"year":2019,"cited_by_count":1},{"year":2018,"cited_by_count":2},{"year":2017,"cited_by_count":1},{"year":2015,"cited_by_count":1},{"year":2014,"cited_by_count":2},{"year":2012,"cited_by_count":4}],"updated_date":"2026-11-06T12:05:46.655746","created_date":"2016-06-24T00:00:00"}