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
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
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DOI：
10.3390/nu10020195
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发表时间：
2018-02-01
期刊：
影响因子：
5.9
通讯作者：
Laforgia, Nicola
中科院分区：
文献类型：
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作者：
Baldassarre, Maria Elisabetta;Di Mauro, Antonio;Laforgia, Nicola
简介：研究益生菌混合物（Vivomixx（（R））、Visbiome（（R））、DeSimone Formulation（（R））; Danisco-DuPont，麦迪逊，威斯康星州，美国）与安慰剂相比治疗母乳喂养婴儿的婴儿绞痛的有效性和安全性。研究方法：一项随机、双盲、安慰剂对照试验在纯母乳喂养的绞痛婴儿中进行，随机分配接受益生菌混合物或安慰剂21天。将婴儿胃肠道事件的结构化日记交给父母完成。还采集粪便样本，使用粪便实时聚合酶链反应（qPCR）和基于核磁共振（NMR）的分析评价微生物含量和代谢组。研究注册于ClinicalTrials.gov（NCT 01869426）。结果：53名纯母乳喂养的婴儿完成了为期三周的益生菌混合物（n = 27）或安慰剂（n = 26）治疗。在整个研究期间，到治疗期结束时，接受益生菌混合物的婴儿每天哭泣的分钟数较少（68.4分钟/天vs. 98.7分钟/天; p = 0.001）。益生菌混合物组婴儿在第14、12天对第5天（p = 0.04）和第21、26天对第17天（p = 0.001）对治疗有反应的比率较高（定义为从基线减少50%的哭泣时间）。通过10 cm视觉模拟量表评估，益生菌混合物组的父母在第14天报告了更高的生活质量，7.1 +/- 1.2 vs. 7.7 +/- 0.9（p = 0.02）;在第21天，6.7 +/- 1.6 vs. 5.9 +/- 1.0（p = 0.001）。在人体测量数据、排便、粪便稠度或微生物群组成方面，未发现组间差异。发现益生菌影响粪便分子谱。未报告不良事件。结论：益生菌混合物的管理似乎是安全的，并减少纯母乳喂养的婴儿伤心哭泣。
Introduction: To investigate the effectiveness and the safety of a probiotic-mixture (Vivomixx((R)), Visbiome((R)), DeSimone Formulation((R)); 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.