Zhang Faming, Kamm Michael A, Wu Xia, Kao Dina, Borody Thomas J, Chen Lea Ann, He Xingxiang, Fischer Monika, Wong Sunny H, Ng Siew C, Cui Bota, Chan Francis K-L, Nie Yongzhan, Sood Ajit, Li Jingnan, Sun Yang, Dai Ishikawa, Chen Qiyi, Lv Muhan, Zhang Zulun, Ianiro Gianluca, Yang Yunsheng, Kelly Colleen R
Department of Microbiota Medicine and Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Department of Gastroenterology, St Vincent's Hospital, Melbourne, Victoria, Australia.
J Gastroenterol Hepatol. 2025 Jun;40(6):1364-1373. doi: 10.1111/jgh.16947. Epub 2025 Mar 27.
Microbiotherapy has opened new avenues for managing dysbiosis-related diseases. However, many studies did not cover all the necessary reporting items for microbiotherapy making the interpretation of results, safety assessment, technology extension, and even the transparency of legitimacy difficult. This project consisted of 2 phases. First, we proposed an initial preferred reporting items for microbiotherapy (PRIM) checklist and applied it to oncology studies from 2011 to 2023 according to Meta-Analyses guideline. Only 39.3% (n = 64) of these studies (n = 163) met all PRIM checklist items. The culture-based microbiotherapy (CMT) studies had higher score than non-culture-based (NMT) ones (p = 0.018). In the second phase, the expert panel consisting of 22 specialists from eight countries across Asia, Australia, Europe, and North America refined and finalized the PRIM guidelines (named as PRIM 2024) through Delphi consensus. The PRIM 2024 guidelines conclude 10 statements and 18 points on diagnosis, delivery route, source, classification, preparation, dosage, state, concomitant treatment, efficacy, and safety. The panel defined less than 80% of all PRIM points (14 points) as low-quality reports. These guidelines are recommended for reporting on microbiotherapy in clinical studies and reports on compassionate use, including but not limited to fecal microbiota transplantation, phage therapy, probiotics, and synbiotics. These consistent and transparent reporting items can help researchers and practitioners better evaluate, compare, implement research findings in microbiotherapy.
微生物疗法为治疗与菌群失调相关的疾病开辟了新途径。然而，许多研究并未涵盖微生物疗法所有必要的报告项目，这使得结果解读、安全性评估、技术推广，甚至合法性的透明度都变得困难。本项目包括两个阶段。首先，我们提出了微生物疗法首选报告项目（PRIM）初始清单，并根据Meta分析指南将其应用于2011年至2023年的肿瘤学研究。在这些研究（n = 163）中，只有39.3%（n = 64）的研究符合PRIM清单的所有项目。基于培养的微生物疗法（CMT）研究的得分高于非基于培养的（NMT）研究（p = 0.018）。在第二阶段，由来自亚洲、澳大利亚、欧洲和北美的八个国家的22名专家组成的专家小组通过德尔菲共识法对PRIM指南进行了完善和定稿（命名为PRIM 2024）。PRIM 2024指南在诊断、给药途径、来源、分类、制备、剂量、状态、联合治疗、疗效和安全性方面总结了10条声明和18点内容。该小组将所有PRIM要点中不到80%（14点）定义为低质量报告。建议在临床研究以及同情用药报告中使用这些指南来报告微生物疗法，包括但不限于粪便微生物群移植、噬菌体疗法、益生菌和合生元。这些一致且透明的报告项目有助于研究人员和从业者更好地评估、比较和应用微生物疗法的研究结果。
