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

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.

The Therapeutic Benefits of Single and Multi-Strain Probiotics on Mean Daily Crying Time and Key Inflammatory Markers in Infantile Colic

“…The subsequent study by Chen et al [ 19 ] examined similar markers and also found an increase in sIgA and butyrate at the end of their 21-day intervention. However, this group found an increase in calprotectin in the fecal samples of the BB-12 group compared to the placebo.…”

“…Bifidobacterium animalis is a gram-positive anaerobic bacterium that naturally colonizes the gut of humans. Three of the studies that met the inclusion criteria for this review examined this single-strain probiotic in the treatment group [19][20][21]. Two of the three studies [19,20] utilized the same concentration of Bifidobacterium animalis subsp.…”

“…Three of the studies that met the inclusion criteria for this review examined this single-strain probiotic in the treatment group [19][20][21]. Two of the three studies [19,20] utilized the same concentration of Bifidobacterium animalis subsp. lactis of 1×10 9 CFU/day.…”

“…A total of 136 infants were examined in the treatment groups, and 136 infants were included in the control groups. One of the studies provided the probiotic intervention for 21 days [ 19 ], and the other study provided the intervention for 28 days [ 20 ]. Both studies showed a significant decrease in the average crying duration in the treatment group compared to the control.…”

Probiotics for the Management of Pediatric Gastrointestinal Disorders: Position Paper of the ESPGHAN Special Interest Group on Gut Microbiota and Modifications

“…A 2021 RCT performed in China (96) in 192 full‐term infants ≤7 weeks, breastfed, with colic according to the Rome III criteria found that compared with placebo, administration of B lactis BB‐12 (1 × 10 9 CFU/day) for 3 weeks significantly increased the treatment success (defined as earlier; RR 2.8, 95% CI: 1.9–4.2). There was also a significant difference between the B lactis BB‐12 and placebo groups in mean daily crying time at the end of intervention (60.8 ± 23.4 vs 95.8 ± 26.0, MD −35 minutes, 95% CI: −42 to −28).…”