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Nutrients 2018, 10(2), 195; doi:10.3390/nu10020195

Effectiveness and Safety of a Probiotic-Mixture for the Treatment of Infantile Colic: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial with Fecal Real-Time PCR and NMR-Based Metabolomics Analysis

1
Neonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70100 Bari, Italy
2
SIGENP (Italian Society of Pediatric Gastroenterology, Hepatology, and Nutrition), via Libero Temolo 4 (Torre UB), 20126 Milan, Italy
3
Section of Hygiene, Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70100 Bari, Italy
4
Department of Public Health and Infectious Disease, “Sapienza” University of Rome, 00100 Rome, Italy
5
Department of Agro-Food Science and Technology, University of Bologna, Piazza Goidanich 60, 47522 Cesena, Italy
*
Author to whom correspondence should be addressed.
Received: 14 January 2018 / Revised: 5 February 2018 / Accepted: 7 February 2018 / Published: 10 February 2018
(This article belongs to the Special Issue Nutrition in Pediatric Gastroenterology: Selected Papers from SIGENP)
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Abstract

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 (n = 27) or a placebo (n = 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; p = 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 (p = 0.04) and on day 21, 26 vs. 17 (p = 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 (p = 0.02); and on day 21, 6.7 ± 1.6 vs. 5.9 ± 1.0 (p = 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. View Full-Text
Keywords: infantile colic; probiotics; metabolomics; microbiota infantile colic; probiotics; metabolomics; microbiota
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Baldassarre, M.E.; Di Mauro, A.; Tafuri, S.; Rizzo, V.; Gallone, M.S.; Mastromarino, P.; Capobianco, D.; Laghi, L.; Zhu, C.; Capozza, M.; Laforgia, N. Effectiveness and Safety of a Probiotic-Mixture for the Treatment of Infantile Colic: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial with Fecal Real-Time PCR and NMR-Based Metabolomics Analysis. Nutrients 2018, 10, 195.

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