Department of Medicine, The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz, Nowy Šwiat 4, 62-800 Kalisz, Poland.
Mother and Child Health Department, Karol Marcinkowski Medical University in Poznań, ul. Fredry 10, 61-701 Poznan, Poland.
Benef Microbes. 2021 Jun 15;12(3):249-257. doi: 10.3920/BM2020.0160. Epub 2021 Mar 26.
The aim of the study was to determine effects of administration of simethicone and a multi-strain synbiotic on the crying behaviour of colicky babies. The study design consisted of an open-label, two parallel treatment group study involving 87 infants aged 3-6 weeks with infantile colic (defined as crying episodes lasting 3 or more hours per day and occurring at least 3 days per week within 3 weeks prior to enrolment) randomly, unequally [1:1.5] assigned to receive simethicone (n=33) or a multi-strain synbiotic (n=54) orally for 4 weeks. The multi-strain synbiotic contained LA-14, R0215, Lp-115, GG, Ls-33, Bl-04, R0071, R0175 and fructooligosaccharides). Primary outcome measures were the responder rates (effect ≥50% reduction from baseline) of the measures 'crying days last 3 weeks', 'average evening crying duration last 3 weeks' and 'reduction of average number of crying phases per day last three weeks' at the end of treatment. The study is registered at ClinicalTrials.gov under NCT04487834. Significantly higher responder rates (effect ≥50% reduction from baseline) of the multi-strain synbiotic compared to simethicone were found for the measures 'crying days last 3 weeks' (72% vs 18%, <0.0001) and 'average evening crying duration last 3 weeks' (85% vs 39%, =0.0001). No significant difference was found for the measure 'reduction of average number of crying phases per day last three weeks' (50% vs 42%, =0.4852). No adverse effects were reported for the two treatment groups. Based on these results, the multi-strain synbiotic can be considered as an interesting therapeutic possibility for the treatment of infantile colic, worthwhile to be investigated further in non-clinical and clinical studies.
本研究旨在确定二甲硅油和多菌株合生剂给药对绞痛婴儿哭闹行为的影响。研究设计包括一项开放标签、两平行处理组研究，共纳入 87 名年龄在 3-6 周的婴儿，患有婴儿绞痛（定义为每天哭闹持续 3 小时或以上，且在入组前 3 周内每周至少 3 天出现），随机、不均等[1:1.5]分为口服二甲硅油组（n=33）或多菌株合生剂组（n=54），疗程为 4 周。多菌株合生剂含有 LA-14、R0215、Lp-115、GG、Ls-33、Bl-04、R0071、R0175 和低聚果糖）。主要结局指标为治疗结束时“过去 3 周哭闹天数”、“过去 3 周平均傍晚哭闹时长”和“过去 3 周平均每日哭闹阶段数减少”的应答率（与基线相比减少≥50%）。该研究在 ClinicalTrials.gov 注册，编号为 NCT04487834。与二甲硅油相比，多菌株合生剂在“过去 3 周哭闹天数”（72% vs 18%，<0.0001）和“过去 3 周平均傍晚哭闹时长”（85% vs 39%，=0.0001）这两个指标上的应答率显著更高（与基线相比减少≥50%）。在“过去 3 周平均每日哭闹阶段数减少”这一指标上（50% vs 42%，=0.4852），两组之间没有显著差异。两组均未报告不良事件。基于这些结果，多菌株合生剂可被视为治疗婴儿绞痛的一种有趣的治疗选择，值得进一步在非临床和临床研究中进行探索。
