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Efficacy of Bifidobacterium animalis subsp. lactis, BB-12® on infant colic - a randomised, double-blinded,
1Department of Nutrition, Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, No. 1617, Riyue Avenue, Qingyang District, Chengdu, 6100131, China P.R.
Insights
Supplementation with Bifidobacterium animalis subsp. lactis, BB-12 (BB-12) significantly reduced crying and fussing time in breastfed infants with colic. This probiotic intervention also improved infant sleep and caregiver quality of life.
Area of Science:
- Pediatrics
- Microbiology
- Gastroenterology
Background:
- Infant colic is a common condition affecting breastfed infants, causing significant distress to both infant and caregiver.
- Current management strategies for infant colic are limited, necessitating exploration of novel therapeutic approaches.
Purpose of the Study:
- To evaluate the efficacy of Bifidobacterium animalis subsp. lactis, BB-12 (BB-12) supplementation in reducing crying and fussing time in breastfed infants diagnosed with colic.
- To assess the impact of BB-12 on infant sleep duration, caregiver quality of life, and relevant immunological biomarkers.
Main Methods:
- A double-blind, placebo-controlled randomized study was conducted with 192 full-term infants (<3 months) meeting ROME III criteria for infant colic.
- Infants received daily BB-12 (1×10^9 cfu/day) or placebo for 3 weeks, following a 1-week run-in period.
- Crying/fussing time, sleep duration, caregiver quality of life (PedsQL™ 2.0), and fecal immunological biomarkers were assessed.
Main Results:
- A significantly higher proportion of infants in the BB-12 group achieved ≥50% reduction in crying/fussing time (P<0.001).
- The BB-12 group showed a significant reduction in crying episodes and a marked increase in sleep duration compared to placebo (P<0.001).
- Fecal levels of human beta defensin 2, cathelicidin, slgA, calprotectin, and butyrate were elevated in the BB-12 group, alongside improved caregiver functioning scores (P<0.05).
Conclusions:
- Supplementation with Bifidobacterium animalis subsp. lactis, BB-12 is effective in alleviating symptoms of infant colic in breastfed infants.
- BB-12 demonstrates benefits beyond symptom reduction, including improved infant sleep, enhanced gut immunity, and better caregiver well-being.
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.
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