Intestinal microbiota transplantation (IMT) has been recognized as an effective treatment for recurrent Clostridium difficile infection (rCDI) and a novel treatment option for other diseases. However, the safety of IMT in patients has not been established. This systematic review and meta-analysis was conducted to assess the safety of IMT. We systematically reviewed all randomized controlled trials (RCTs) of IMT studies published up to 28 February 2021 using databases including PubMed, EMBASE and the Cochrane Library. Studies were excluded if they did not report adverse events (AEs). Two authors independently extracted the data. The relative risk (RR) of serious adverse events (SAEs) and common adverse events (CAEs) were estimated separately, as were predefined subgroups. Publication bias was evaluated by a funnel plot and Egger’s regression test. Among 978 reports, 99 full‐text articles were screened, and 20 articles were included for meta-analysis, involving 1132 patients (603 in the IMT group and 529 in the control group). We found no significant difference in the incidence of SAEs between the IMT group and the control group (RR = 1.36, 95% CI 0.56–3.31, P = 0.50). Of these 20 studies, 7 described the number of patients with CAEs, involving 360 patients (195 in the IMT group and 166 in the control group). An analysis of the eight studies revealed that the incidence of CAEs was also not significantly increased in the IMT group compared with the control group (RR = 1.06, 95% CI 0.91–1.23, P = 0.43). Subgroup analysis showed that the incidence of CAEs was significantly different between subgroups of delivery methods (P(CAE) = 0.04), and the incidence of IMT-related SAEs and CAEs was not significantly different in the other predefined subgroups. Currently, IMT is widely used in many diseases, but its associated AEs should not be ignored. To improve the safety of IMT, patients' conditions should be fully evaluated before IMT, appropriate transplantation methods should be selected, each operative step of faecal bacteria transplantation should be strictly controlled, AE management mechanisms should be improved, and a close follow-up system should be established.

中文翻译：

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随机对照试验中肠道菌群移植的不良事件：系统评价和荟萃分析

肠道菌群移植 (IMT) 已被公认为是复发性艰难梭菌感染 (rCDI) 的有效治疗方法和其他疾病的新治疗选择。然而，尚未确定 IMT 在患者中的安全性。该系统评价和荟萃分析旨在评估 IMT 的安全性。我们使用 PubMed、EMBASE 和 Cochrane 图书馆等数据库系统地回顾了截至 2021 年 2 月 28 日发表的所有 IMT 研究随机对照试验 (RCT)。如果研究没有报告不良事件 (AE)，则将其排除在外。两位作者独立提取数据。严重不良事件 (SAE) 和常见不良事件 (CAE) 的相对风险 (RR) 和预定义的亚组分别估计。通过漏斗图和 Egger 回归检验评估发表偏倚。在978篇报道中，筛选出99篇全文，纳入20篇进行meta分析，涉及1132例患者（IMT组603例，对照组529例）。我们发现 IMT 组和对照组之间 SAE 的发生率没有显着差异（RR = 1.36, 95% CI 0.56–3.31, P = 0.50）。在这 20 项研究中，7 项描述了 CAE 患者的数量，涉及 360 名患者（IMT 组 195 名，对照组 166 名）。对八项研究的分析表明，与对照组相比，IMT 组的 CAE 发生率也没有显着增加（RR = 1.06，95% CI 0.91-1.23，P = 0.43）。亚组分析显示，不同分娩方式的亚组之间 CAE 的发生率存在显着差异（P(CAE) = 0.04），在其他预定义的亚组中，IMT 相关 SAE 和 CAE 的发生率没有显着差异。目前，IMT 广泛应用于多种疾病，但其相关的 AE 也不容忽视。为提高IMT的安全性，IMT前应充分评估患者病情，选择合适的移植方式，严格控制粪菌移植的每一个操作步骤，完善AE管理机制，建立密切的随访制度应成立。