Maria Elisabetta Baldassarre, Antonio Di Mauro, Silvio Tafuri, Valentina Rizzo, Maria Serena Gallone, Paola Mastromarino, Daniela Capobianco, Luca Laghi, Chenglin Zhu, Manuela Capozza, Nicola Laforgia
Journal: Nutrients 2018;10(2):195
PMID: 29439395
Infantile colic is characterised by frequent and lengthy periods of inconsolable crying and affects anywhere from 10-40% of new born babies. It causes significant distress to parents, with repeated doctor visits and various medical interventions are offered to help alleviate the symptoms. This randomised, double-blinded placebo controlled trial of 66 infants diagnosed with colic, aimed to assess the efficacy and safety of a multi-strain probiotic in reducing colic symptoms in exclusively breast-fed infants. The probiotic or placebo were administered over a 3-week period, with parents keeping structured diaries and the researchers taking faecal samples at enrolment and after 21 days of treatment. Infants receiving the probiotic mixture had significantly less minutes of crying per day in comparison to the placebo group. A higher quality of life for the treatment group was also reported by the parents. No differences were reported between groups on infant growth, bowel movements or intestinal bacteria profile and no adverse events were reported. The authors of the study conclude that administration of a multi-strain probiotic appears safe and reduces inconsolable crying in exclusively breast-fed infants.
INTRODUCTION
To investigate the effectiveness and the safety of a probiotic-mixture (Vivomixx, Visbiome, DeSimone Formulation; Danisco-DuPont, Madison, WI, USA) for the treatment of infantile colic in breastfed infants, compared with a placebo.
METHODS
A randomized, double-blind, placebo-controlled trial was conducted in exclusively breastfed infants with colic, randomly assigned to receive a probiotic-mixture or a placebo for 21 days. A structured diary of gastrointestinal events of the infants was given to the parents to complete. Samples of feces were also collected to evaluate microbial content and metabolome using fecal real-time polymerase chain reaction (qPCR) and Nuclear magnetic resonance (NMR)-based analysis. Study registered at ClinicalTrials.gov (NCT01869426).
RESULTS
Fifty-three exclusively-breastfed infants completed three weeks of treatment with a probiotic-mixture ( = 27) or a placebo ( = 26). Infants receiving the probiotic-mixture had less minutes of crying per day throughout the study by the end of treatment period (68.4 min/day vs. 98.7 min/day; = 0.001). A higher rate of infants from the probiotic-mixture group responded to treatment (defined by reduction of crying times of ≥50% from baseline), on day 14, 12 vs. 5 ( = 0.04) and on day 21, 26 vs. 17 ( = 0.001). A higher quality of life, assessed by a 10-cm visual analogue scale, was reported by parents of the probiotic-mixture group on day 14, 7.1 ± 1.2 vs. 7.7 ± 0.9 ( = 0.02); and on day 21, 6.7 ± 1.6 vs. 5.9 ± 1.0 ( = 0.001). No differences between groups were found regarding anthropometric data, bowel movements, stool consistency or microbiota composition. Probiotics were found to affect the fecal molecular profile. No adverse events were reported.
CONCLUSIONS
Administration of a probiotic-mixture appears safe and reduces inconsolable crying in exclusively breastfed infants.
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