van den Nieuwboer M, Brummer R J, Guarner F, Morelli L, Cabana M, Claassen E
1 VU University Amsterdam, Athena Institute, De Boelelaan 1085, 1081 HV Amsterdam, the Netherlands.
2 School of Health and Medical Sciences, Örebro University, 701 82 Örebro, Sweden.
Benef Microbes. 2015;6(5):615-30. doi: 10.3920/BM2014.0157. Epub 2015 Apr 22.
This study aimed to systematically evaluate safety of probiotics and synbiotics in children ageing 0-18 years. This study is the third and final part in a safety trilogy and an update is provided using the most recent available clinical data (2008-2013) by means of the Common Terminology Clinical Adverse Events (CTCAE version 4.0) classification. Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. Analysis of 74 clinical studies indicated that probiotic and/or synbiotic administration in children is safe with regard to the specific evaluated strains, dosages and duration. The population of children include healthy, immune compromised and obese subjects, as well as subjects with intestinal disorders, infections and inflammatory disorders. This study revealed no major safety concerns, as the adverse events (AEs) were unrelated, or not suspected to be related, to the probiotic or synbiotic product. In general the study products were well tolerated. Overall, AEs occurred more frequent in the control arm compared to children receiving probiotics and/or synbiotics. Furthermore, the results indicate inadequate reporting and classification of AEs in the majority of the studies. In addition, generalizability of conclusions are greatly limited by the inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes.
本研究旨在系统评估0至18岁儿童使用益生菌和合生元的安全性。本研究是安全性三部曲的第三部分也是最后一部分,通过通用临床不良事件术语(CTCAE第4.0版)分类,利用最新可得的临床数据(2008 - 2013年)进行更新。安全性方面通过每种益生菌菌株/培养物的参与者数量、研究持续时间、剂量、临床状况和选定疾病来体现并关联。对74项临床研究的分析表明,就特定评估的菌株、剂量和持续时间而言,儿童使用益生菌和/或合生元是安全的。儿童群体包括健康、免疫功能低下和肥胖的受试者,以及患有肠道疾病、感染和炎症性疾病的受试者。本研究未发现重大安全问题,因为不良事件与益生菌或合生元产品无关,或未怀疑与之相关。总体而言,研究产品耐受性良好。总体而言,与接受益生菌和/或合生元的儿童相比,对照组中不良事件发生得更频繁。此外,结果表明大多数研究中不良事件的报告和分类不充分。此外,结论的可推广性受到报告不一致、不准确和可能不完整以及益生菌菌株、剂量、给药方案、研究人群和报告结果的差异的极大限制。
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