The therapeutic efficacy of Bifidobacterium animalis subsp. lactis BB‐12® in infant colic: A randomised, double blind, placebo‐controlled trial
Summary Background The pathogenesis of infant colic is poorly defined. Gut microbiota seems to be involved, supporting the potential therapeutic role of probiotics. Aims To assess the rate of infants with a reduction of ≥50% of mean daily crying duration after 28 days of intervention with the probio...
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Veröffentlicht in: | Alimentary pharmacology & therapeutics 2020-01, Vol.51 (1), p.110-120 |
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creator | Nocerino, Rita De Filippis, Francesca Cecere, Gaetano Marino, Antonio Micillo, Maria Di Scala, Carmen Caro, Carmen Calignano, Antonio Bruno, Cristina Paparo, Lorella Iannicelli, Anna M. Cosenza, Linda Maddalena, Ylenia Gatta, Giusy Coppola, Serena Carucci, Laura Ercolini, Danilo Berni Canani, Roberto |
description | Summary
Background
The pathogenesis of infant colic is poorly defined. Gut microbiota seems to be involved, supporting the potential therapeutic role of probiotics.
Aims
To assess the rate of infants with a reduction of ≥50% of mean daily crying duration after 28 days of intervention with the probiotic Bifidobacterium animalis subsp. lactis BB‐12® (BB‐12). Secondary outcomes were daily number of crying episodes, sleeping time, number of bowel movements and stool consistency.
Methods
Randomized controlled trial (RCT) on otherwise healthy exclusively breastfed infants with infant colic randomly allocated to receive BB‐12 (1 × 109 CFU/day) or placebo for 28 days. Gut microbiota structure and butyrate, beta‐defensin‐2 (HBD‐2), cathelicidin (LL‐37), secretory IgA (sIgA) and faecal calprotectin levels were assessed.
Results
Eighty infants were randomised, 40/group. The rate of infants with reduction of ≥50% of mean daily crying duration was higher in infants treated with BB‐12, starting from the end of 2nd week. No infant relapsed when treatment was stopped. The mean number of crying episodes decreased in both groups, but with a higher effect in BB‐12 group (−4.7 ± 3.4 vs −2.3 ± 2.2, P |
doi_str_mv | 10.1111/apt.15561 |
format | Article |
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Background
The pathogenesis of infant colic is poorly defined. Gut microbiota seems to be involved, supporting the potential therapeutic role of probiotics.
Aims
To assess the rate of infants with a reduction of ≥50% of mean daily crying duration after 28 days of intervention with the probiotic Bifidobacterium animalis subsp. lactis BB‐12® (BB‐12). Secondary outcomes were daily number of crying episodes, sleeping time, number of bowel movements and stool consistency.
Methods
Randomized controlled trial (RCT) on otherwise healthy exclusively breastfed infants with infant colic randomly allocated to receive BB‐12 (1 × 109 CFU/day) or placebo for 28 days. Gut microbiota structure and butyrate, beta‐defensin‐2 (HBD‐2), cathelicidin (LL‐37), secretory IgA (sIgA) and faecal calprotectin levels were assessed.
Results
Eighty infants were randomised, 40/group. The rate of infants with reduction of ≥50% of mean daily crying duration was higher in infants treated with BB‐12, starting from the end of 2nd week. No infant relapsed when treatment was stopped. The mean number of crying episodes decreased in both groups, but with a higher effect in BB‐12 group (−4.7 ± 3.4 vs −2.3 ± 2.2, P < 0.05). Mean daily stool frequency decreased in both groups but the effect was significantly higher in the BB‐12 group; stool consistency was similar between the two groups. An increase in Bifidobacterium abundance (with significant correlation with crying time reduction), butyrate and HBD‐2, LL‐37, sIgA levels associated with a decrease in faecal calprotectin level were observed in the BB‐12 group.
Conclusions
Supplementation with BB‐12 is effective in managing infant colic. The effect could derive from immune and non‐immune mechanisms associated with a modulation of gut microbiota structure and function.</description><identifier>ISSN: 0269-2813</identifier><identifier>ISSN: 1365-2036</identifier><identifier>EISSN: 1365-2036</identifier><identifier>DOI: 10.1111/apt.15561</identifier><identifier>PMID: 31797399</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>Babies ; Bifidobacterium animalis ; Breast Feeding ; Colic - diet therapy ; Colic - microbiology ; Crying ; Defecation ; Double-Blind Method ; Double-blind studies ; Feces - microbiology ; Female ; Gastrointestinal Microbiome - physiology ; Humans ; Immunoglobulin A ; Infant ; Infant Care - methods ; Infantile colic ; Infants ; Intestinal microflora ; Intestine ; Male ; Microbiota ; Placebos ; Probiotics ; Probiotics - therapeutic use ; Randomised Clinical Trial ; Randomization ; Structure-function relationships ; Supplements ; Treatment Outcome</subject><ispartof>Alimentary pharmacology & therapeutics, 2020-01, Vol.51 (1), p.110-120</ispartof><rights>2019 The Authors. Published by John Wiley & Sons Ltd</rights><rights>2019 The Authors. Alimentary Pharmacology & Therapeutics Published by John Wiley & Sons Ltd.</rights><rights>Copyright © 2020 John Wiley & Sons Ltd</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4431-6034dc95f6a84d8a83597f733eccb63627d09cc03e1f73186f4c456a17f27d0a3</citedby><cites>FETCH-LOGICAL-c4431-6034dc95f6a84d8a83597f733eccb63627d09cc03e1f73186f4c456a17f27d0a3</cites><orcidid>0000-0003-4681-546X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fapt.15561$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fapt.15561$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,780,784,885,1417,1433,27924,27925,45574,45575,46409,46833</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31797399$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nocerino, Rita</creatorcontrib><creatorcontrib>De Filippis, Francesca</creatorcontrib><creatorcontrib>Cecere, Gaetano</creatorcontrib><creatorcontrib>Marino, Antonio</creatorcontrib><creatorcontrib>Micillo, Maria</creatorcontrib><creatorcontrib>Di Scala, Carmen</creatorcontrib><creatorcontrib>Caro, Carmen</creatorcontrib><creatorcontrib>Calignano, Antonio</creatorcontrib><creatorcontrib>Bruno, Cristina</creatorcontrib><creatorcontrib>Paparo, Lorella</creatorcontrib><creatorcontrib>Iannicelli, Anna M.</creatorcontrib><creatorcontrib>Cosenza, Linda</creatorcontrib><creatorcontrib>Maddalena, Ylenia</creatorcontrib><creatorcontrib>Gatta, Giusy</creatorcontrib><creatorcontrib>Coppola, Serena</creatorcontrib><creatorcontrib>Carucci, Laura</creatorcontrib><creatorcontrib>Ercolini, Danilo</creatorcontrib><creatorcontrib>Berni Canani, Roberto</creatorcontrib><title>The therapeutic efficacy of Bifidobacterium animalis subsp. lactis BB‐12® in infant colic: A randomised, double blind, placebo‐controlled trial</title><title>Alimentary pharmacology & therapeutics</title><addtitle>Aliment Pharmacol Ther</addtitle><description>Summary
Background
The pathogenesis of infant colic is poorly defined. Gut microbiota seems to be involved, supporting the potential therapeutic role of probiotics.
Aims
To assess the rate of infants with a reduction of ≥50% of mean daily crying duration after 28 days of intervention with the probiotic Bifidobacterium animalis subsp. lactis BB‐12® (BB‐12). Secondary outcomes were daily number of crying episodes, sleeping time, number of bowel movements and stool consistency.
Methods
Randomized controlled trial (RCT) on otherwise healthy exclusively breastfed infants with infant colic randomly allocated to receive BB‐12 (1 × 109 CFU/day) or placebo for 28 days. Gut microbiota structure and butyrate, beta‐defensin‐2 (HBD‐2), cathelicidin (LL‐37), secretory IgA (sIgA) and faecal calprotectin levels were assessed.
Results
Eighty infants were randomised, 40/group. The rate of infants with reduction of ≥50% of mean daily crying duration was higher in infants treated with BB‐12, starting from the end of 2nd week. No infant relapsed when treatment was stopped. The mean number of crying episodes decreased in both groups, but with a higher effect in BB‐12 group (−4.7 ± 3.4 vs −2.3 ± 2.2, P < 0.05). Mean daily stool frequency decreased in both groups but the effect was significantly higher in the BB‐12 group; stool consistency was similar between the two groups. An increase in Bifidobacterium abundance (with significant correlation with crying time reduction), butyrate and HBD‐2, LL‐37, sIgA levels associated with a decrease in faecal calprotectin level were observed in the BB‐12 group.
Conclusions
Supplementation with BB‐12 is effective in managing infant colic. The effect could derive from immune and non‐immune mechanisms associated with a modulation of gut microbiota structure and function.</description><subject>Babies</subject><subject>Bifidobacterium animalis</subject><subject>Breast Feeding</subject><subject>Colic - diet therapy</subject><subject>Colic - microbiology</subject><subject>Crying</subject><subject>Defecation</subject><subject>Double-Blind Method</subject><subject>Double-blind studies</subject><subject>Feces - microbiology</subject><subject>Female</subject><subject>Gastrointestinal Microbiome - physiology</subject><subject>Humans</subject><subject>Immunoglobulin A</subject><subject>Infant</subject><subject>Infant Care - methods</subject><subject>Infantile colic</subject><subject>Infants</subject><subject>Intestinal microflora</subject><subject>Intestine</subject><subject>Male</subject><subject>Microbiota</subject><subject>Placebos</subject><subject>Probiotics</subject><subject>Probiotics - therapeutic use</subject><subject>Randomised Clinical Trial</subject><subject>Randomization</subject><subject>Structure-function relationships</subject><subject>Supplements</subject><subject>Treatment Outcome</subject><issn>0269-2813</issn><issn>1365-2036</issn><issn>1365-2036</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>EIF</sourceid><recordid>eNp1kc2KFDEQx4Mo7rh68AUk4EXBns1Hd9LtQZhZ_IIFPYznkE4nTpZM0ibdytx8BA8-hw_ho_gk1jjrooIhEKrqV3-q8kfoPiVLCudMj9OSNo2gN9CCctFUjHBxEy0IE13FWspP0J1SLgkhQhJ2G51wKjvJu26Bvm62Fk9bm_Vo58kbbJ3zRps9Tg6vvfND6rWZbPbzDuvodzr4gsvcl3GJA1QgWq9_fP5C2fdv2Ee4TscJmxS8eYpXOOs4pJ0vdniChzT3weI--AjRCO22T9BrUpxyCsEOeMpeh7voltOh2HtX7yl69-L55vxVdfHm5evz1UVl6prTShBeD6ZrnNBtPbS65U0nneTcGtMLLpgcSGcM4ZZClrbC1aZuhKbSHUqan6JnR91x7nd2MBbG0EGNGdbMe5W0V39Xot-q9-mjEvB7rGlB4NGVQE4fZlsmBZsaG4KONs1FMc6oEI1kAtCH_6CXac4R1jtQspUSnATq8ZEyOZWSrbsehhJ18FqB1-qX18A--HP6a_K3uQCcHYFPPtj9_5XU6u3mKPkTIcu3Xw</recordid><startdate>202001</startdate><enddate>202001</enddate><creator>Nocerino, Rita</creator><creator>De Filippis, Francesca</creator><creator>Cecere, Gaetano</creator><creator>Marino, Antonio</creator><creator>Micillo, Maria</creator><creator>Di Scala, Carmen</creator><creator>Caro, Carmen</creator><creator>Calignano, Antonio</creator><creator>Bruno, Cristina</creator><creator>Paparo, Lorella</creator><creator>Iannicelli, Anna M.</creator><creator>Cosenza, Linda</creator><creator>Maddalena, Ylenia</creator><creator>Gatta, Giusy</creator><creator>Coppola, Serena</creator><creator>Carucci, Laura</creator><creator>Ercolini, Danilo</creator><creator>Berni Canani, Roberto</creator><general>Wiley Subscription Services, Inc</general><general>John Wiley and Sons Inc</general><scope>24P</scope><scope>WIN</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7TK</scope><scope>7U9</scope><scope>H94</scope><scope>M7N</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0003-4681-546X</orcidid></search><sort><creationdate>202001</creationdate><title>The therapeutic efficacy of Bifidobacterium animalis subsp. lactis BB‐12® in infant colic: A randomised, double blind, placebo‐controlled trial</title><author>Nocerino, Rita ; De Filippis, Francesca ; Cecere, Gaetano ; Marino, Antonio ; Micillo, Maria ; Di Scala, Carmen ; Caro, Carmen ; Calignano, Antonio ; Bruno, Cristina ; Paparo, Lorella ; Iannicelli, Anna M. ; Cosenza, Linda ; Maddalena, Ylenia ; Gatta, Giusy ; Coppola, Serena ; Carucci, Laura ; Ercolini, Danilo ; Berni Canani, Roberto</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4431-6034dc95f6a84d8a83597f733eccb63627d09cc03e1f73186f4c456a17f27d0a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Babies</topic><topic>Bifidobacterium animalis</topic><topic>Breast Feeding</topic><topic>Colic - diet therapy</topic><topic>Colic - microbiology</topic><topic>Crying</topic><topic>Defecation</topic><topic>Double-Blind Method</topic><topic>Double-blind studies</topic><topic>Feces - microbiology</topic><topic>Female</topic><topic>Gastrointestinal Microbiome - physiology</topic><topic>Humans</topic><topic>Immunoglobulin A</topic><topic>Infant</topic><topic>Infant Care - methods</topic><topic>Infantile colic</topic><topic>Infants</topic><topic>Intestinal microflora</topic><topic>Intestine</topic><topic>Male</topic><topic>Microbiota</topic><topic>Placebos</topic><topic>Probiotics</topic><topic>Probiotics - therapeutic use</topic><topic>Randomised Clinical Trial</topic><topic>Randomization</topic><topic>Structure-function relationships</topic><topic>Supplements</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Nocerino, Rita</creatorcontrib><creatorcontrib>De Filippis, Francesca</creatorcontrib><creatorcontrib>Cecere, Gaetano</creatorcontrib><creatorcontrib>Marino, Antonio</creatorcontrib><creatorcontrib>Micillo, Maria</creatorcontrib><creatorcontrib>Di Scala, Carmen</creatorcontrib><creatorcontrib>Caro, Carmen</creatorcontrib><creatorcontrib>Calignano, Antonio</creatorcontrib><creatorcontrib>Bruno, Cristina</creatorcontrib><creatorcontrib>Paparo, Lorella</creatorcontrib><creatorcontrib>Iannicelli, Anna M.</creatorcontrib><creatorcontrib>Cosenza, Linda</creatorcontrib><creatorcontrib>Maddalena, Ylenia</creatorcontrib><creatorcontrib>Gatta, Giusy</creatorcontrib><creatorcontrib>Coppola, Serena</creatorcontrib><creatorcontrib>Carucci, Laura</creatorcontrib><creatorcontrib>Ercolini, Danilo</creatorcontrib><creatorcontrib>Berni Canani, Roberto</creatorcontrib><collection>Wiley Online Library (Open Access Collection)</collection><collection>Wiley Free Content</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Alimentary pharmacology & therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Nocerino, Rita</au><au>De Filippis, Francesca</au><au>Cecere, Gaetano</au><au>Marino, Antonio</au><au>Micillo, Maria</au><au>Di Scala, Carmen</au><au>Caro, Carmen</au><au>Calignano, Antonio</au><au>Bruno, Cristina</au><au>Paparo, Lorella</au><au>Iannicelli, Anna M.</au><au>Cosenza, Linda</au><au>Maddalena, Ylenia</au><au>Gatta, Giusy</au><au>Coppola, Serena</au><au>Carucci, Laura</au><au>Ercolini, Danilo</au><au>Berni Canani, Roberto</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The therapeutic efficacy of Bifidobacterium animalis subsp. lactis BB‐12® in infant colic: A randomised, double blind, placebo‐controlled trial</atitle><jtitle>Alimentary pharmacology & therapeutics</jtitle><addtitle>Aliment Pharmacol Ther</addtitle><date>2020-01</date><risdate>2020</risdate><volume>51</volume><issue>1</issue><spage>110</spage><epage>120</epage><pages>110-120</pages><issn>0269-2813</issn><issn>1365-2036</issn><eissn>1365-2036</eissn><abstract>Summary
Background
The pathogenesis of infant colic is poorly defined. Gut microbiota seems to be involved, supporting the potential therapeutic role of probiotics.
Aims
To assess the rate of infants with a reduction of ≥50% of mean daily crying duration after 28 days of intervention with the probiotic Bifidobacterium animalis subsp. lactis BB‐12® (BB‐12). Secondary outcomes were daily number of crying episodes, sleeping time, number of bowel movements and stool consistency.
Methods
Randomized controlled trial (RCT) on otherwise healthy exclusively breastfed infants with infant colic randomly allocated to receive BB‐12 (1 × 109 CFU/day) or placebo for 28 days. Gut microbiota structure and butyrate, beta‐defensin‐2 (HBD‐2), cathelicidin (LL‐37), secretory IgA (sIgA) and faecal calprotectin levels were assessed.
Results
Eighty infants were randomised, 40/group. The rate of infants with reduction of ≥50% of mean daily crying duration was higher in infants treated with BB‐12, starting from the end of 2nd week. No infant relapsed when treatment was stopped. The mean number of crying episodes decreased in both groups, but with a higher effect in BB‐12 group (−4.7 ± 3.4 vs −2.3 ± 2.2, P < 0.05). Mean daily stool frequency decreased in both groups but the effect was significantly higher in the BB‐12 group; stool consistency was similar between the two groups. An increase in Bifidobacterium abundance (with significant correlation with crying time reduction), butyrate and HBD‐2, LL‐37, sIgA levels associated with a decrease in faecal calprotectin level were observed in the BB‐12 group.
Conclusions
Supplementation with BB‐12 is effective in managing infant colic. The effect could derive from immune and non‐immune mechanisms associated with a modulation of gut microbiota structure and function.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>31797399</pmid><doi>10.1111/apt.15561</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0003-4681-546X</orcidid><oa>free_for_read</oa></addata></record> |
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source | MEDLINE; Access via Wiley Online Library; Wiley Free Content; EZB-FREE-00999 freely available EZB journals |
subjects | Babies Bifidobacterium animalis Breast Feeding Colic - diet therapy Colic - microbiology Crying Defecation Double-Blind Method Double-blind studies Feces - microbiology Female Gastrointestinal Microbiome - physiology Humans Immunoglobulin A Infant Infant Care - methods Infantile colic Infants Intestinal microflora Intestine Male Microbiota Placebos Probiotics Probiotics - therapeutic use Randomised Clinical Trial Randomization Structure-function relationships Supplements Treatment Outcome |
title | The therapeutic efficacy of Bifidobacterium animalis subsp. lactis BB‐12® in infant colic: A randomised, double blind, placebo‐controlled trial |
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