{"id":"https://openalex.org/W7223246793","doi":"https://doi.org/10.3390/nu18213468","title":"Efficacy of a Limosilactobacillus reuteri DSM 17938 and BG-R46\u00ae Formulation in Predominantly Breastfed Infants with Infant Distress Syndrome: A Randomized Double-Blind Placebo-Controlled Trial","display_name":"Efficacy of a Limosilactobacillus reuteri DSM 17938 and BG-R46\u00ae Formulation in Predominantly Breastfed Infants with Infant Distress Syndrome: A Randomized Double-Blind Placebo-Controlled Trial","publication_year":2026,"publication_date":"2026-10-22","ids":{"openalex":"https://openalex.org/W7223246793","doi":"https://doi.org/10.3390/nu18213468"},"language":"en","primary_location":{"id":"doi:10.3390/nu18213468","doi":"https://doi.org/10.3390/nu18213468","is_oa":true,"landing_page_url":"https://doi.org/10.3390/nu18213468","pdf_url":null,"source":{"id":"https://openalex.org/S110785341","display_name":"Nutrients","issn_l":"2072-6643","issn":["2072-6643"],"is_oa":true,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","ki-jl-1","medline","norway-1","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310310987","host_organization_name":"Multidisciplinary Digital Publishing Institute","host_organization_lineage":["https://openalex.org/P4310310987"],"host_organization_lineage_names":["Multidisciplinary Digital Publishing Institute"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Nutrients","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref"],"open_access":{"is_oa":true,"oa_status":"gold","oa_url":"https://doi.org/10.3390/nu18213468","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5088441820","display_name":"Flavia Indrio","orcid":"https://orcid.org/0000-0001-9789-7878","observed_orcids":["https://orcid.org/0000-0001-9789-7878"]},"institutions":[{"id":"https://openalex.org/I142910587","display_name":"University of Salento","ror":"https://ror.org/03fc1k060","country_code":"IT","type":"education","lineage":["https://openalex.org/I142910587"]}],"countries":["IT"],"is_corresponding":true,"raw_author_name":"Flavia Indrio","raw_affiliation_strings":["Department of Experimental Medicine, Pediatric Section, Medical School MedTech, University of Salento, 73100 Lecce, Italy"],"raw_orcid":"https://orcid.org/0000-0001-9789-7878","affiliations":[{"raw_affiliation_string":"Department of Experimental Medicine, Pediatric Section, Medical School MedTech, University of Salento, 73100 Lecce, Italy","institution_ids":["https://openalex.org/I142910587"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5022012392","display_name":"Luca Pecoraro","orcid":"https://orcid.org/0000-0002-9765-8006","observed_orcids":["https://orcid.org/0000-0002-9765-8006"]},"institutions":[{"id":"https://openalex.org/I142910587","display_name":"University of Salento","ror":"https://ror.org/03fc1k060","country_code":"IT","type":"education","lineage":["https://openalex.org/I142910587"]},{"id":"https://openalex.org/I4210152598","display_name":"Ospedale Vito Fazzi","ror":"https://ror.org/04fvmv716","country_code":"IT","type":"healthcare","lineage":["https://openalex.org/I4210099368","https://openalex.org/I4210117053","https://openalex.org/I4210152598"]}],"countries":["IT"],"is_corresponding":false,"raw_author_name":"Luca Pecoraro","raw_affiliation_strings":["Department of Experimental Medicine, Pediatric Section, Medical School MedTech, University of Salento, 73100 Lecce, Italy","Pediatric Unit, Ospedale Vito Fazzi, ASL Lecce, 73100 Lecce, Italy"],"raw_orcid":"https://orcid.org/0000-0002-9765-8006","affiliations":[{"raw_affiliation_string":"Department of Experimental Medicine, Pediatric Section, Medical School MedTech, University of Salento, 73100 Lecce, Italy","institution_ids":["https://openalex.org/I142910587"]},{"raw_affiliation_string":"Pediatric Unit, Ospedale Vito Fazzi, ASL Lecce, 73100 Lecce, Italy","institution_ids":["https://openalex.org/I4210152598"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5159296982","display_name":"Pierluigi Manni","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Pierluigi Manni","raw_affiliation_strings":["Pediatric Primary Care, National Pediatric Health Care System, ASL Lecce, 73100 Lecce, Italy"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Pediatric Primary Care, National Pediatric Health Care System, ASL Lecce, 73100 Lecce, Italy","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5020685943","display_name":"Valeria Verdesca","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Valeria Verdesca","raw_affiliation_strings":["Pediatric Primary Care, National Pediatric Health Care System, ASL Lecce, 73100 Lecce, Italy"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Pediatric Primary Care, National Pediatric Health Care System, ASL Lecce, 73100 Lecce, Italy","institution_ids":[]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5021358285","display_name":"Antonio Di Mauro","orcid":"https://orcid.org/0000-0001-7052-9784","observed_orcids":["https://orcid.org/0000-0001-7052-9784"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Antonio Di Mauro","raw_affiliation_strings":["Pediatric Primary Care, National Pediatric Health Care System, ASL Bari, 70100 Bari, Italy"],"raw_orcid":"https://orcid.org/0000-0001-7052-9784","affiliations":[{"raw_affiliation_string":"Pediatric Primary Care, National Pediatric Health Care System, ASL Bari, 70100 Bari, Italy","institution_ids":[]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":2,"corresponding_author_ids":["https://openalex.org/A5088441820"],"corresponding_institution_ids":["https://openalex.org/I142910587"],"apc_list":{"value":2900,"currency":"CHF","value_usd":3499},"apc_paid":{"value":2900,"currency":"CHF","value_usd":3499},"fwci":0.0,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":{"value":0.84330389,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":"18","issue":"21","first_page":"3468","last_page":"3468"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T13289","display_name":"Infant Health and Development","score":0.9990000128746033,"subfield":{"id":"https://openalex.org/subfields/2735","display_name":"Pediatrics, Perinatology and Child Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T13289","display_name":"Infant Health and Development","score":0.9990000128746033,"subfield":{"id":"https://openalex.org/subfields/2735","display_name":"Pediatrics, Perinatology and Child Health"},"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/T11294","display_name":"Infant Nutrition and Health","score":0.0003000000142492354,"subfield":{"id":"https://openalex.org/subfields/2916","display_name":"Nutrition and Dietetics"},"field":{"id":"https://openalex.org/fields/29","display_name":"Nursing"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10141","display_name":"Probiotics and Fermented Foods","score":0.00019999999494757503,"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"}}],"keywords":[{"id":"https://openalex.org/keywords/infantile-colic","display_name":"infantile colic","score":0.9639999866485596},{"id":"https://openalex.org/keywords/probiotics","display_name":"probiotics","score":0.8370000123977661},{"id":"https://openalex.org/keywords/infant-crying","display_name":"infant crying","score":0.718999981880188},{"id":"https://openalex.org/keywords/postpartum-depression","display_name":"postpartum depression","score":0.7559999823570251},{"id":"https://openalex.org/keywords/gut-brain-axis","display_name":"gut-brain axis","score":0.7490000128746033},{"id":"https://openalex.org/keywords/probiotic-formulation","display_name":"probiotic formulation","score":0.7039999961853027}],"concepts":[{"id":"https://openalex.org/C2778013503","wikidata":"https://www.wikidata.org/wiki/Q152247","display_name":"Crying","level":2,"score":0.911300003528595},{"id":"https://openalex.org/C2775898472","wikidata":"https://www.wikidata.org/wiki/Q597078","display_name":"Lactobacillus reuteri","level":4,"score":0.9035000205039978},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.7699999809265137},{"id":"https://openalex.org/C2778375690","wikidata":"https://www.wikidata.org/wiki/Q7814214","display_name":"Tolerability","level":3,"score":0.715499997138977},{"id":"https://openalex.org/C27081682","wikidata":"https://www.wikidata.org/wiki/Q269829","display_name":"Placebo","level":3,"score":0.7120000123977661},{"id":"https://openalex.org/C139265228","wikidata":"https://www.wikidata.org/wiki/Q5283089","display_name":"Distress","level":2,"score":0.6517999768257141},{"id":"https://openalex.org/C168563851","wikidata":"https://www.wikidata.org/wiki/Q1436668","display_name":"Randomized controlled trial","level":2,"score":0.5830000042915344},{"id":"https://openalex.org/C187212893","wikidata":"https://www.wikidata.org/wiki/Q123028","display_name":"Pediatrics","level":1,"score":0.5705000162124634},{"id":"https://openalex.org/C2776283161","wikidata":"https://www.wikidata.org/wiki/Q174876","display_name":"Breastfeeding","level":2,"score":0.5015000104904175},{"id":"https://openalex.org/C2780255968","wikidata":"https://www.wikidata.org/wiki/Q1816730","display_name":"Probiotic","level":3,"score":0.487199991941452},{"id":"https://openalex.org/C203092338","wikidata":"https://www.wikidata.org/wiki/Q1340863","display_name":"Clinical endpoint","level":3,"score":0.46219998598098755},{"id":"https://openalex.org/C2779150110","wikidata":"https://www.wikidata.org/wiki/Q2287198","display_name":"Infant formula","level":2,"score":0.41670000553131104},{"id":"https://openalex.org/C2776882568","wikidata":"https://www.wikidata.org/wiki/Q5338245","display_name":"Edinburgh Postnatal Depression Scale","level":4,"score":0.3946000039577484},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.3630000054836273},{"id":"https://openalex.org/C202061045","wikidata":"https://www.wikidata.org/wiki/Q7200267","display_name":"Placebo-controlled study","level":5,"score":0.3580000102519989},{"id":"https://openalex.org/C3020294031","wikidata":"https://www.wikidata.org/wiki/Q174876","display_name":"Breast feeding","level":2,"score":0.34790000319480896},{"id":"https://openalex.org/C2779002586","wikidata":"https://www.wikidata.org/wiki/Q39059161","display_name":"Infant crying","level":3,"score":0.33820000290870667},{"id":"https://openalex.org/C2776867660","wikidata":"https://www.wikidata.org/wiki/Q1814941","display_name":"Depression (economics)","level":2,"score":0.3149000108242035},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.28610000014305115},{"id":"https://openalex.org/C2992213488","wikidata":"https://www.wikidata.org/wiki/Q85769412","display_name":"Infant feeding","level":3,"score":0.28529998660087585},{"id":"https://openalex.org/C202953159","wikidata":"https://www.wikidata.org/wiki/Q382695","display_name":"Intention-to-treat analysis","level":3,"score":0.2720000147819519},{"id":"https://openalex.org/C2776814716","wikidata":"https://www.wikidata.org/wiki/Q574801","display_name":"Sedation","level":2,"score":0.25540000200271606},{"id":"https://openalex.org/C141983124","wikidata":"https://www.wikidata.org/wiki/Q188008","display_name":"Respiratory distress","level":2,"score":0.25519999861717224},{"id":"https://openalex.org/C2992764375","wikidata":"https://www.wikidata.org/wiki/Q407784","display_name":"Infant development","level":2,"score":0.25049999356269836}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.3390/nu18213468","doi":"https://doi.org/10.3390/nu18213468","is_oa":true,"landing_page_url":"https://doi.org/10.3390/nu18213468","pdf_url":null,"source":{"id":"https://openalex.org/S110785341","display_name":"Nutrients","issn_l":"2072-6643","issn":["2072-6643"],"is_oa":true,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","ki-jl-1","medline","norway-1","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310310987","host_organization_name":"Multidisciplinary Digital Publishing Institute","host_organization_lineage":["https://openalex.org/P4310310987"],"host_organization_lineage_names":["Multidisciplinary Digital Publishing Institute"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Nutrients","raw_type":"journal-article"}],"best_oa_location":{"id":"doi:10.3390/nu18213468","doi":"https://doi.org/10.3390/nu18213468","is_oa":true,"landing_page_url":"https://doi.org/10.3390/nu18213468","pdf_url":null,"source":{"id":"https://openalex.org/S110785341","display_name":"Nutrients","issn_l":"2072-6643","issn":["2072-6643"],"is_oa":true,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","ki-jl-1","medline","norway-1","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310310987","host_organization_name":"Multidisciplinary Digital Publishing Institute","host_organization_lineage":["https://openalex.org/P4310310987"],"host_organization_lineage_names":["Multidisciplinary Digital Publishing Institute"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Nutrients","raw_type":"journal-article"},"sustainable_development_goals":[{"score":0.9922999739646912,"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3"}],"study_designs":[{"display_name":"Randomized Controlled Trial","id":"https://openalex.org/study-designs/randomized-controlled-trial"},{"display_name":"Clinical Trial","id":"https://openalex.org/study-designs/clinical-trial"}],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":34,"referenced_works":["https://openalex.org/W1972190510","https://openalex.org/W1997182468","https://openalex.org/W2022494444","https://openalex.org/W2024660361","https://openalex.org/W2040244187","https://openalex.org/W2040680839","https://openalex.org/W2105001422","https://openalex.org/W2136909898","https://openalex.org/W2142075465","https://openalex.org/W2142128479","https://openalex.org/W2147739127","https://openalex.org/W2149264570","https://openalex.org/W2152053744","https://openalex.org/W2234740317","https://openalex.org/W2604359107","https://openalex.org/W2757554167","https://openalex.org/W2778074450","https://openalex.org/W2889122852","https://openalex.org/W2970686316","https://openalex.org/W4214660869","https://openalex.org/W4304203408","https://openalex.org/W4308957986","https://openalex.org/W4309607787","https://openalex.org/W4376504074","https://openalex.org/W4405844024","https://openalex.org/W4409483458","https://openalex.org/W4410930214","https://openalex.org/W4411157238","https://openalex.org/W4415063364","https://openalex.org/W4416479656","https://openalex.org/W7129696134","https://openalex.org/W7130724611","https://openalex.org/W7155219466","https://openalex.org/W7161626980"],"related_works":["https://openalex.org/W2022494444","https://openalex.org/W1972190510","https://openalex.org/W4403287926","https://openalex.org/W2778074450","https://openalex.org/W7216943274","https://openalex.org/W2015315093","https://openalex.org/W7156353117","https://openalex.org/W7129518730","https://openalex.org/W2136909898","https://openalex.org/W2033788056"],"abstract_inverted_index":{"Background:":[0],"Infant":[1],"distress":[2,137,191,201,259],"syndrome,":[3],"previously":[4],"termed":[5],"Infantile":[6],"colic,":[7],"is":[8],"a":[9,48,61],"common":[10],"disorder":[11],"of":[12,75,143],"gut\u2013brain":[13],"interaction":[14],"characterized":[15],"by":[16,204],"excessive":[17],"crying":[18,149,159],"and":[19,73,120,147,167,172,186,233],"impaired":[20],"behavioral":[21,162],"regulation.":[22],"Although":[23],"Limosilactobacillus":[24],"reuteri":[25,249,254],"DSM":[26,52,76,250],"17938":[27,77,251],"has":[28],"shown":[29],"efficacy":[30,72],"in":[31,57,83,117,134,206,212],"predominantly":[32],"breastfed":[33],"infants,":[34],"treatment":[35],"responses":[36],"remain":[37],"variable,":[38],"highlighting":[39],"the":[40,65,71,102,118,127,141,152,180,207,213,243],"need":[41],"to":[42,99,131],"investigate":[43],"alternative":[44],"probiotic":[45,103,208,237],"formulations.":[46],"BG-R46\u2122,":[47],"strain":[49],"derived":[50],"from":[51,129],"17938,":[53],"exhibits":[54],"distinct":[55],"properties":[56],"preclinical":[58],"models,":[59],"providing":[60],"rationale":[62],"for":[63,107],"evaluating":[64],"combined":[66],"formulation.":[67],"This":[68],"study":[69],"investigated":[70],"tolerability":[74],"plus":[78,252],"BG-R46\u2122":[79,255],"compared":[80,260],"with":[81,85,247,261],"placebo":[82,106,214],"infants":[84,96,111],"infantile":[86],"colic.":[87],"Methods:":[88],"In":[89],"this":[90],"randomized,":[91],"double-blind,":[92],"placebo-controlled":[93],"trial,":[94],"50":[95],"were":[97,115],"randomized":[98],"receive":[100],"either":[101],"formulation":[104,238],"or":[105],"21":[108],"days.":[109],"Forty-eight":[110],"(24":[112],"per":[113],"group)":[114],"included":[116,158],"intention-to-treat":[119],"per-protocol":[121],"analyses.":[122],"The":[123,236],"primary":[124],"endpoint":[125],"was":[126,193,239],"change":[128],"baseline":[130],"Day":[132,154,198,228],"7":[133],"total":[135],"infant":[136,161,190,200,258],"time,":[138,160],"defined":[139],"as":[140],"sum":[142],"awake":[144,166,170],"fussing,":[145,171],"crying,":[146],"inconsolable":[148,173],"recorded":[150],"using":[151,179],"Baby\u2019s":[153],"Diary\u00ae.":[155],"Secondary":[156],"outcomes":[157],"regulation":[163],"(sleep":[164],"duration,":[165],"content":[168],"behavior,":[169],"crying),":[174],"maternal":[175],"emotional":[176],"well-being":[177],"assessed":[178],"Edinburgh":[181],"Postnatal":[182],"Depression":[183],"Scale":[184],"(EPDS),":[185],"safety.":[187],"Results:":[188],"Baseline":[189],"time":[192,202],"comparable":[194],"between":[195],"groups.":[196],"At":[197,227],"7,":[199],"decreased":[203],"43%":[205],"group":[209,215],"versus":[210],"13%":[211],"(\u2212236.0":[216],"\u00b1":[217,221],"111.5":[218],"vs.":[219],"\u221266.7":[220],"100.1":[222],"min/day;":[223],"p":[224],"<":[225],"0.001).":[226],"21,":[229],"reductions":[230],"reached":[231],"62%":[232],"26%,":[234],"respectively.":[235],"well":[240],"tolerated":[241],"throughout":[242],"study.":[244],"Conclusions:":[245],"Supplementation":[246],"L.":[248,253],"significantly":[256],"reduced":[257],"placebo.":[262]},"counts_by_year":[],"updated_date":"2026-11-01T11:40:01.658920","created_date":"2026-10-23T00:00:00"}
