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The therapeutic efficacy of Bifidobacterium animalis subsp. lactis BB-12® in infant colic: A randomised, double blind, placebo-controlled trial.


ABSTRACT: 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.

SUBMITTER: Nocerino R 

PROVIDER: S-EPMC6973258 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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The therapeutic efficacy of Bifidobacterium animalis subsp. lactis BB-12<sup>®</sup> in infant colic: A randomised, double blind, placebo-controlled trial.

Nocerino Rita R   De Filippis Francesca F   Cecere Gaetano G   Marino Antonio A   Micillo Maria M   Di Scala Carmen C   de Caro Carmen C   Calignano Antonio A   Bruno Cristina C   Paparo Lorella L   Iannicelli Anna M AM   Cosenza Linda L   Maddalena Ylenia Y   Della Gatta Giusy G   Coppola Serena S   Carucci Laura L   Ercolini Danilo D   Berni Canani Roberto R  

Alimentary pharmacology & therapeutics 20191203 1


<h4>Background</h4>The pathogenesis of infant colic is poorly defined. Gut microbiota seems to be involved, supporting the potential therapeutic role of probiotics.<h4>Aims</h4>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<sup>®</sup> (BB-12). Secondary outcomes were daily number of crying episodes, sleeping time, number of bowel movements and stool consistency.<h4  ...[more]

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