Efficacy and safety of a probiotic-mixture for the treatment of infantile colic: a double-blind, randomized, placebo-controlled clinical trial

NUTRITION: Neonatal and infant nutrition N-O-001 Efficacy and safety of a probiotic-mixture for the treatment of infantile colic: a double-blind, randomized, placebo-controlled clinical trial Maria Elisabetta Baldassarre1, Manuela Capozza1, Valentina Rizzo1, Silvio Tafuri1, Antonio Di Mauro2, Nicola Laforgia1 1"Aldo Moro" University of Bari, Department of Biomedical Science and Human Oncology, Bari, Italy 2University of Bari "Aldo Moro", Neonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, Bari, Italy Objectives and study: Infantile colic is a causes parental distress and medical effort. Recent evidences suggest that infantile colic is low-grade systemic inflammation and Manipulation of the gut microbiota with probiotic supplementation seems to play a   therapeutic role in colic management. Aim of this study was to investigate the effectiveness and the safety of a probiotic- mixture (containing Lactobacillus plantarum DSM 24730, Streptococcus thermophilus DSM 24731, Bifidobacterium breve DSM 24732, Lactobacillus paracasei DSM 24733, Lactobacillus delbrueckii subsp. bulgaricus DSM 24734, Lactobacillus acidophilus DSM 24735, Bifidobacterium longum DSM 24736, Bifidobacterium infantis DSM 24737 and currently sold under the brand Vivomixx® in Continental Europe and Visbiome® in USA and Canada) for the treatment of infantile colic in breastfed infants, compared with placebo. Methods: A randomized, double blind, placebo-controlled trial was conducted involving exclusively breastfed infants with colic, randomly assigned to receive a probiotic-mixture or placebo for 21 days. A structured diary on gastrointestinal events in newborns, such as number of minutes of inconsolable crying per day, number of regurgitation episodes per day, number of bowel movements per day and stool consistency, was given to parents. Diaries, infants’ anthropometrics and type of adverse events were monitored weekly. The trial was registered to Clinicaltrial.gov at number: NCT01869426. Results: 59 exclusively breastfed infants completed the 3 weeks of probiotic-mixture (n.28) or placebo (n.31) treatment. Infants given probiotic-mixture showed a significant reduction in average daily episodes of fussing at the end of treatment period, compared with those receiving placebo (6,5±9,1 vs 12,7±12,7; p=0,01). Also average minutes of crying per episode on day 21 is shorter compared with infants given placebo (34,3±36,7 minutes vs 65,8±50,2 minutes; p=0,009). Total average minutes of inconsolable crying per day throughout the study were significantly shorter among colic infant in the treatment group compared with those of placebo group and reached statistical significance at the end of treatment period (214,8±338,3 minutes vs 710,4±716,0 minutes; p=0,00). No differences between groups are collected regarding infants’ anthropometric data, number of regurgitation episodes per day, number of bowel movements per day and stool consistency (p>0.05). No adverse events were reported related to the study intervention. Conclusion: Administration of a probiotic-mixture for the treatment of infantile colic is safe and significantly reduces minutes of inconsolable crying per day in exclusively breastfed infants with colic.