Department of Translational Medicine and Surgery, Università Cattolica del Sacro Cuore, Rome, Italy; UOC Gastroenterologia and UOC CEMAD Medicina Interna e Gastroenterologia, Department of Medical and Surgical Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.
Systems Immunology Department, Weizmann Institute of Science, Rehovot, Israel; Medical Clinic III, University Hospital Aachen, Aachen, Germany.
Lancet Gastroenterol Hepatol. 2024 May;9(5):460-475. doi: 10.1016/S2468-1253(23)00357-6.
The gut microbiome is acknowledged as a key determinant of human health, and technological progress in the past two decades has enabled the deciphering of its composition and functions and its role in human disorders. Therefore, manipulation of the gut microbiome has emerged as a promising therapeutic option for communicable and non-communicable disorders. Full exploitation of current therapeutic microbiome modulators (including probiotics, prebiotics, and faecal microbiota transplantation) is hindered by several factors, including poor precision, regulatory and safety issues, and the impossibility of providing reproducible and targeted treatments. Artificial microbiota therapeutics (which include a wide range of products, such as microbiota consortia, bacteriophages, bacterial metabolites, and engineered probiotics) have appeared as an evolution of current microbiota modulators, as they promise safe and reproducible effects, with variable levels of precision via different pathways. We describe the landscape of artificial microbiome therapeutics, from those already on the market to those still in the pipeline, and outline the major challenges for positioning these therapeutics in clinical practice.
肠道微生物组被认为是人类健康的关键决定因素，过去二十年的技术进步使人们能够解读其组成和功能及其在人类疾病中的作用。因此，操纵肠道微生物组已成为治疗传染性和非传染性疾病的一种有前途的治疗选择。目前的治疗性微生物组调节剂（包括益生菌、益生元和粪便微生物移植）的充分利用受到多种因素的限制，包括精度差、监管和安全问题，以及无法提供可重复和靶向的治疗。人工微生物组治疗剂（包括微生物群落、噬菌体、细菌代谢物和工程益生菌等多种产品）作为当前微生物组调节剂的一种发展，已经出现，因为它们有望通过不同的途径产生安全且可重复的效果，精度也有所不同。我们描述了人工微生物组治疗剂的现状，包括已经上市的和仍在研发中的治疗剂，并概述了将这些治疗剂定位在临床实践中的主要挑战。
