Kolaček Sanja, Hojsak Iva, Berni Canani Roberto, Guarino Alfredo, Indrio Flavia, Orel Rok, Pot Bruno, Shamir Raanan, Szajewska Hania, Vandenplas Yvan, van Goudoever Johannes, Weizman Zvi
*Children's Hospital Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia †Department of Translational Medical Sciences, Paediatric Section, and CEINGE Advanced Biotechnology, and European Laboratory for the Investigation of Food Induced Diseases (ELFID), University of Naples Federico II ‡Department of Translational Medical Sciences, Paediatric Section, University Federico II, Naples §Department of Paediatric Gastroenterology Division, Ospedale Pediatrico Giovanni XXIII University of Bari, Bari, Italy ||Department of Gastroenterology, Hepatology and Nutrition, University Medical Centre Ljubljana, University Children's Hospital Ljubljana, Ljubljana, Slovenia ¶Department IMDO, Vrije Universiteit Brussel, Brussels, Belgium #Institute for Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel **The Medical University of Warsaw, Department of Paediatrics, Warsaw, Poland ††UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium ‡‡Emma Children's Hospital-AMC and VU University Medical Center, Amsterdam, The Netherlands §§Ben-Gurion University, Faculty of Health Sciences, Beer-Sheva, Israel.
J Pediatr Gastroenterol Nutr. 2017 Jul;65(1):117-124. doi: 10.1097/MPG.0000000000001603.
Probiotics have been proposed for a number of indications ranging from the hypothetical long-term immunomodulatory effects to proven benefits in the management of different clinical conditions.An increasing number of commercial products containing probiotics are available. In those products, irrespective if it is food, food supplement, medical food, or drug, the probiotic microorganisms have to be present in a sufficient number by the end of the shelf-life, to pass through the gastrointestinal tract resisting acid and bile, to colonize the gut, and to retain functional properties required to obtain the suggested beneficial effect. Finally, it should be contamination-free.Studies organized worldwide and summarized in this article have shown that inconsistencies and deviations from the information provided on the product label are surprisingly common. Frequently strains are misidentified and misclassified, products are occasionally contaminated, sometimes with even facultative or obligatory pathogens, strains are not viable, the labeled number of colonies cannot be verified, or the functional properties are diminished to the extent that preclude the proposed health benefit. As the probiotic preparations are commonly used for a wide range of conditions, the aim of the Working Group was to summarize results of the studies looking into the quality of the probiotic products and to raise the awareness of the important issue of their quality control.Based on the results obtained, we strongly suggest a more stringent quality control process. This process should ensure that the probiotic content as mentioned on the label meets the actual content throughout the shelf life of the product, while no contamination is present.
益生菌已被应用于多种适应症，从假设的长期免疫调节作用到在不同临床病症管理中已证实的益处。市面上含有益生菌的商业产品越来越多。在这些产品中，无论其为食品、食品补充剂、医用食品还是药品，益生菌微生物在保质期结束时都必须有足够数量，能够抵抗胃酸和胆汁通过胃肠道，在肠道中定殖，并保持获得建议有益效果所需的功能特性。最后，产品应无污染。全球范围内组织开展并在本文中总结的研究表明，产品标签上提供的信息存在不一致和偏差的情况出奇地普遍。菌株经常被错误鉴定和分类，产品偶尔会被污染，有时甚至被兼性或专性病原菌污染，菌株没有活力，标签上标注的菌落数量无法核实或者功能特性降低到无法实现所宣称的健康益处的程度。由于益生菌制剂常用于多种病症，工作组的目的是总结有关益生菌产品质量的研究结果，并提高对其质量控制这一重要问题的认识。基于所获得的结果，我们强烈建议采用更严格的质量控制流程。该流程应确保产品标签上提及的益生菌含量在产品的整个保质期内都符合实际含量，同时不存在污染。
