PMID- 35619175 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220716 IS - 1757-4749 (Print) IS - 1757-4749 (Electronic) IS - 1757-4749 (Linking) VI - 14 IP - 1 DP - 2022 May 26 TI - Adverse events of intestinal microbiota transplantation in randomized controlled trials: a systematic review and meta-analysis. PG - 20 LID - 10.1186/s13099-022-00491-3 [doi] LID - 20 AB - BACKGROUND: 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. AIMS: This systematic review and meta-analysis was conducted to assess the safety of IMT. METHODS: 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. RESULTS: 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. CONCLUSION: 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. CI - (c) 2022. The Author(s). FAU - Chen, Chong AU - Chen C AD - Department of Gastroenterology, The First Affiliated Hospital of Shenzhen University, Shenzhen Second People's Hospital, Shenzhen, 518037, China. FAU - Chen, Liyu AU - Chen L AD - Department of Gastroenterology, 923Th Hospital of PLA Joint Logistics Support Force, Nanning, 530021, China. FAU - Sun, Dayong AU - Sun D AD - Department of Gastroenterology, The First Affiliated Hospital of Shenzhen University, Shenzhen Second People's Hospital, Shenzhen, 518037, China. FAU - Li, Cailan AU - Li C AD - Department of Gastroenterology, 923Th Hospital of PLA Joint Logistics Support Force, Nanning, 530021, China. FAU - Xi, Shiheng AU - Xi S AD - Department of Gastroenterology, 923Th Hospital of PLA Joint Logistics Support Force, Nanning, 530021, China. FAU - Ding, Shihua AU - Ding S AD - Department of Gastroenterology, The First Affiliated Hospital of Shenzhen University, Shenzhen Second People's Hospital, Shenzhen, 518037, China. FAU - Luo, Rongrong AU - Luo R AD - Department of Gastroenterology, 923Th Hospital of PLA Joint Logistics Support Force, Nanning, 530021, China. FAU - Geng, Yan AU - Geng Y AUID- ORCID: 0000-0002-5124-6444 AD - Department of Gastroenterology, 923Th Hospital of PLA Joint Logistics Support Force, Nanning, 530021, China. drggyn@163.com. FAU - Bai, Yang AU - Bai Y AD - Guangdong Provincial Key Laboratory of Gastroenterology, Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China. 13925001665@163.com. LA - eng PT - Journal Article PT - Review DEP - 20220526 PL - England TA - Gut Pathog JT - Gut pathogens JID - 101474263 PMC - PMC9134705 OTO - NOTNLM OT - Adverse events OT - Intestinal microbiota transplantation OT - Meta-analysis OT - Randomized controlled trials COIS- The authors have no conflicts of interest to declare. EDAT- 2022/05/27 06:00 MHDA- 2022/05/27 06:01 PMCR- 2022/05/26 CRDT- 2022/05/26 23:50 PHST- 2021/05/29 00:00 [received] PHST- 2022/04/11 00:00 [accepted] PHST- 2022/05/26 23:50 [entrez] PHST- 2022/05/27 06:00 [pubmed] PHST- 2022/05/27 06:01 [medline] PHST- 2022/05/26 00:00 [pmc-release] AID - 10.1186/s13099-022-00491-3 [pii] AID - 491 [pii] AID - 10.1186/s13099-022-00491-3 [doi] PST - epublish SO - Gut Pathog. 2022 May 26;14(1):20. doi: 10.1186/s13099-022-00491-3.