{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T13:00:28Z","timestamp":1792069228559,"version":"4.4.0"},"reference-count":43,"publisher":"MDPI AG","issue":"2","license":[{"start":{"date-parts":[[2018,2,10]],"date-time":"2018-02-10T00:00:00Z","timestamp":1518220800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Nutrients"],"abstract":"<jats:p>Introduction: To investigate the effectiveness and the safety of a probiotic-mixture (Vivomixx\u00ae, Visbiome\u00ae, DeSimone Formulation\u00ae; 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 \u226550% 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 \u00b1 1.2 vs. 7.7 \u00b1 0.9 (p = 0.02); and on day 21, 6.7 \u00b1 1.6 vs. 5.9 \u00b1 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.<\/jats:p>","DOI":"10.3390\/nu10020195","type":"journal-article","created":{"date-parts":[[2018,2,12]],"date-time":"2018-02-12T10:50:38Z","timestamp":1518432638000},"page":"195","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":62,"title":["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"],"prefix":"10.3390","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0590-6664","authenticated-orcid":false,"given":"Maria","family":"Baldassarre","sequence":"first","affiliation":[{"name":"Neonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70100 Bari, Italy"},{"name":"SIGENP (Italian Society of Pediatric Gastroenterology, Hepatology, and Nutrition), via Libero Temolo 4 (Torre UB), 20126 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7052-9784","authenticated-orcid":false,"given":"Antonio","family":"Di Mauro","sequence":"additional","affiliation":[{"name":"Neonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70100 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvio","family":"Tafuri","sequence":"additional","affiliation":[{"name":"Section of Hygiene, Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70100 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valentina","family":"Rizzo","sequence":"additional","affiliation":[{"name":"Neonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70100 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Gallone","sequence":"additional","affiliation":[{"name":"Section of Hygiene, Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70100 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paola","family":"Mastromarino","sequence":"additional","affiliation":[{"name":"Department of Public Health and Infectious Disease, \u201cSapienza\u201d University of Rome, 00100 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniela","family":"Capobianco","sequence":"additional","affiliation":[{"name":"Department of Public Health and Infectious Disease, \u201cSapienza\u201d University of Rome, 00100 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1593-7376","authenticated-orcid":false,"given":"Luca","family":"Laghi","sequence":"additional","affiliation":[{"name":"Department of Agro-Food Science and Technology, University of Bologna, Piazza Goidanich 60, 47522 Cesena, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3486-1936","authenticated-orcid":false,"given":"Chenglin","family":"Zhu","sequence":"additional","affiliation":[{"name":"Department of Agro-Food Science and Technology, University of Bologna, Piazza Goidanich 60, 47522 Cesena, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manuela","family":"Capozza","sequence":"additional","affiliation":[{"name":"Neonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70100 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4610-1216","authenticated-orcid":false,"given":"Nicola","family":"Laforgia","sequence":"additional","affiliation":[{"name":"Neonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70100 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2018,2,10]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"398","DOI":"10.1136\/adc.84.5.398","article-title":"Systematic review of the occurrence of infantile colic in the community","volume":"84","author":"Lucassen","year":"2001","journal-title":"Arch. 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