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

In: Beneficial Microbes
Authors:
K. Chen Department 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.
Department of Child Health Care, Chengdu New Century Women’s and Children’s Hospital, No.77, Baojia Lane, Qingyang District, Chengdu, China P.R.

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G. Zhang Department of Pediatric Intensive Care Unit, 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, China P.R.

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H. Xie Department of Pediatrics, Dayi Maternal and Child Health Care Hospital, No. 539, Inner Mongolia Avenue, Jinyuan Town, Dayi County, Chengdu, China P.R.

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L. You Department of Child Health Care, Nanxin Community Health Service Center, N0. 168, Guanghe 1st Street, Wuhou District, Chengdu, China P.R.

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H. Li Department of Child Health Care, Qingbaijiang Maternal and Child Health Care Hospital, No.87, Qingjiang South Road, Qingbaijiang District, Chengdu, China P.R.

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Y. Zhang Department of Child Health Care, Jinniu Maternal and Child Health Care Hospital, No.12, Changyue Road, Jinniu District, Chengdu, China P.R.

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C. Du Department of Child Health Care, Longquanyi Maternal and Child Health Care Hospital, No.383, Yuyang Road, Longquanyi District, Chengdu, China P.R.

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S. Xu Department of Child Health Care, Huili Maternal and Child Health Care Hospital, No. 41, Jindai Road West Section, Guoyuan Township, Huili County, Xichang, China P.R.

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C. Melsaether Chr. Hansen A/S, HH Clinical Development, Kogle Alle 6, 2970 Hoersholm, Denmark.

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S. Yuan Department 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.

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Open Access

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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