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Efficacy of Bifidobacterium animalis subsp. lactis, BB-12® on infant colic - a randomised, double-blinded, placebo-controlled study.

  • 2021-11-16
  • Beneficial Microbes 12(6)
    • K. Chen
    • G. Zhang
    • H. Xie
    • L. You
    • H. Li
    • Y. Zhang
    • C. Du
    • S. Xu
    • C. Melsaether
    • S. Yuan

Abstract

To evaluate the administration of Bifidobacterium animalis subsp. lactis, BB-12® (BB-12) on infant colic in breastfed infants, a double-blind, placebo-controlled randomised study was conducted in Chengdu, China from April 2016 to October 2017 with 192 full-term infants less than 3 months of age and meeting the ROME III criteria for infant colic. After a 1-week run-in the infants were randomly assigned to receive daily BB-12 (1×109 cfu/day) or placebo for 3 weeks. Crying/fussing time were recorded using a 24 h structured diary. The primary endpoint was the proportion of infants achieving a reduction in crying and fussing time of ≥50% from baseline. Parent's/caregiver's health related quality of life was measured using a modified PedsQL™ 2.0 Family Impact Module and immunological biomarkers were evaluated from faecal samples at baseline and after the 21-day intervention. The percentage of infants achieving a reduction in the daily crying/fussing time ≥50% after the 21-day intervention was significantly higher in the infants supplemented with BB-12 (P<0.001). The mean number of crying episodes was significantly reduced in the BB-12 group compared to the placebo group (10.0±3.0 to 5.0±1.87 vs 10.5±2.6 to 7.5±2.8, respectively) (P<0.001) and the mean daily sleep duration was markedly increased from baseline to end of intervention in the BB-12 group compared to the infants in the placebo group (60.7±104.0 vs 31.9±102.7 min/day, respectively) (P<0.001). The faecal levels of human beta defensin 2, cathelicidin, slgA, calprotectin and butyrate were statistically higher in the BB-12 group compared to the placebo group after the 21-day intervention. At the end of the intervention the parent's/caregiver's physical, emotional and social functioning scores were significantly higher for the BB-12 group compared to the placebo group (all P<0.05). Supplementation of BB-12 is effective in reducing crying and fussing in infants diagnosed with infant colic.

Keywords: Bifidobacterium; excessive fussing and crying; probiotics.

Research Insights

SupplementHealth OutcomeEffect TypeEffect Size
Bifidobacterium bifidum BB-06Improved Immunological BiomarkersBeneficial
Moderate
Bifidobacterium bifidum BB-06Improved Parent/Caregiver Health-Related Quality of LifeBeneficial
Large
Bifidobacterium bifidum BB-06Increased Sleep Duration in InfantsBeneficial
Large
Bifidobacterium bifidum BB-06Reduced Inconsolable Crying EpisodesBeneficial
Large
Bifidobacterium bifidum/lactis Bb-02Increased Daily Sleep DurationBeneficial
Large
Bifidobacterium bifidum/lactis Bb-02Increased Fecal Immunological BiomarkersBeneficial
Moderate
Bifidobacterium bifidum/lactis Bb-02Reduced Inconsolable Crying EpisodesBeneficial
Large
Bifidobacterium lactis Bb-02Improved Parent/Caregiver Quality of LifeBeneficial
Large
Bifidobacterium lactis Bb-02Improved Sleep DurationBeneficial
Large
Bifidobacterium lactis Bb-02Increased Fecal Immunological BiomarkersBeneficial
Moderate
Bifidobacterium lactis Bb-02Reduced Inconsolable Crying EpisodesBeneficial
Large
Bifidobacterium lactis BB-12Improved Immunological BiomarkersBeneficial
Moderate
Bifidobacterium lactis BB-12Improved Parent/Caregiver Quality of LifeBeneficial
Large
Bifidobacterium lactis BB-12Increased Daily Sleep DurationBeneficial
Large
Bifidobacterium lactis BB-12Reduced Inconsolable Crying EpisodesBeneficial
Large
Bifidobacterium lactis HDS Bb-02Increased Daily Sleep DurationBeneficial
Large
Bifidobacterium lactis HDS Bb-02Increased Fecal Immunological BiomarkersBeneficial
Moderate
Bifidobacterium lactis HDS Bb-02Reduced Inconsolable Crying EpisodesBeneficial
Large

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