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Nutrients. 2018 Feb 10;10(2). pii: E195. 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.

Author information

1
Neonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70100 Bari, Italy. mariaelisabetta.baldassarre@uniba.it.
2
SIGENP (Italian Society of Pediatric Gastroenterology, Hepatology, and Nutrition), via Libero Temolo 4 (Torre UB), 20126 Milan, Italy. mariaelisabetta.baldassarre@uniba.it.
3
Neonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70100 Bari, Italy. antonio.dimauro@uniba.it.
4
Section of Hygiene, Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70100 Bari, Italy. silvio.tafuri@uniba.it.
5
Neonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70100 Bari, Italy. rizzo.vale@libero.it.
6
Section of Hygiene, Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70100 Bari, Italy. serenagallone@gmail.com.
7
Department of Public Health and Infectious Disease, "Sapienza" University of Rome, 00100 Rome, Italy. paola.mastromarino@uniroma1.it.
8
Department of Public Health and Infectious Disease, "Sapienza" University of Rome, 00100 Rome, Italy. daniela.capobianco@uniroma1.it.
9
Department of Agro-Food Science and Technology, University of Bologna, Piazza Goidanich 60, 47522 Cesena, Italy. l.laghi@unibo.it.
10
Department of Agro-Food Science and Technology, University of Bologna, Piazza Goidanich 60, 47522 Cesena, Italy. chenglin.zhu2@unibo.it.
11
Neonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70100 Bari, Italy. manuela.capozza@uniba.it.
12
Neonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70100 Bari, Italy. nicola.laforgia@uniba.it.

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.

KEYWORDS:

infantile colic; metabolomics; microbiota; probiotics

PMID:
29439395
PMCID:
PMC5852771
DOI:
10.3390/nu10020195
[Indexed for MEDLINE]
Free PMC Article

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