Article Publish Status: FREE
Abstract Title:

Efficacy ofsubsp., BB-12on infant colic - a randomised, double-blinded, placebo-controlled study.

Abstract Source:

Benef Microbes. 2021 Nov 16 ;12(6):531-540. Epub 2021 Sep 22. PMID: 34550055

Abstract Author(s):

K Chen, G Zhang, H Xie, L You, H Li, Y Zhang, C Du, S Xu, C Melsaether, S Yuan

Article Affiliation:

K Chen


To evaluate the administration ofsubsp., 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 (1×10cfu/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 PedsQL2.0 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 (<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) (<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) (<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<0.05). Supplementation of BB-12 is effective in reducing crying and fussing in infants diagnosed with infant colic.

Study Type : Human Study

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