PMID- 27529553 OWN - NLM STAT- MEDLINE DCOM- 20170802 LR - 20231105 IS - 1932-6203 (Electronic) IS - 1932-6203 (Linking) VI - 11 IP - 8 DP - 2016 TI - Systematic Review: Adverse Events of Fecal Microbiota Transplantation. PG - e0161174 LID - 10.1371/journal.pone.0161174 [doi] LID - e0161174 AB - BACKGROUND: Fecal microbiota transplantation (FMT) is a microbiota-based therapy that shows therapeutic potential in recurrent or refractory Clostridium difficile infections and other intestinal or extra-intestinal disorders. Nonetheless, adverse events (AEs) remain a major challenge in the application of FMT. AIM: To review the AEs of FMT and to address the concerns of safety during the procedure. METHODS: Publications were retrieved in the databases of Medline, Embase and Cochrane Library. AEs were classified according to their causality with FMT or their severity. RESULTS: A total of 7562 original articles about FMT were identified in this study, 50 of them fulfilled the inclusion criteria. Totally 78 kinds of AEs were revealed enrolled in these 50 selected publications. The total incidence rate of AEs was 28.5%. Among the 42 publications, 5 kinds were definitely and 38 kinds were probably related to FMT. The commonest FMT-attributable AE was abdominal discomfort, which was reported in 19 publications. For upper gastrointestinal routes of FMT, 43.6% (89/204) patients were compromised by FMT-attributable AE, while the incidence dropped to 17.7% (76/430) for lower gastrointestinal routes. In contrast, the incidences of serious adverse events (SAEs) were 2.0% (4/196) and 6.1% (40/659) for upper and lower gastrointestinal routes, respectively. A total of 44 kinds of SAEs occurred in 9.2% patients, including death (3.5%, 38/1089), infection (2.5%, 27/1089), relapse of inflammatory bowel diseases (0.6%, 7/1089) and Clostridium difficile infection (0.9%, 10/1089). CONCLUSION: Consequently, both AEs and SAEs are not rare and should be carefully monitored throughout FMT. However, high quality randomized controlled trials are still needed for the more definite incidence of AEs of FMT. FAU - Wang, Sinan AU - Wang S AD - Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China. FAU - Xu, Mengque AU - Xu M AD - Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China. FAU - Wang, Weiqiang AU - Wang W AD - Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China. FAU - Cao, Xiaocang AU - Cao X AD - Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China. FAU - Piao, Meiyu AU - Piao M AD - Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China. FAU - Khan, Samiullah AU - Khan S AD - Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China. FAU - Yan, Fang AU - Yan F AD - Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China. AD - Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN 37232, United States of America. FAU - Cao, Hailong AU - Cao H AD - Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China. AD - Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN 37232, United States of America. FAU - Wang, Bangmao AU - Wang B AD - Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China. LA - eng PT - Journal Article PT - Review PT - Systematic Review DEP - 20160816 PL - United States TA - PLoS One JT - PloS one JID - 101285081 SB - IM MH - Fecal Microbiota Transplantation/*adverse effects MH - Humans MH - Safety PMC - PMC4986962 COIS- Competing Interests: The authors have declared that no competing interests exist. EDAT- 2016/08/17 06:00 MHDA- 2017/08/03 06:00 PMCR- 2016/08/16 CRDT- 2016/08/17 06:00 PHST- 2016/02/27 00:00 [received] PHST- 2016/08/01 00:00 [accepted] PHST- 2016/08/17 06:00 [entrez] PHST- 2016/08/17 06:00 [pubmed] PHST- 2017/08/03 06:00 [medline] PHST- 2016/08/16 00:00 [pmc-release] AID - PONE-D-16-08421 [pii] AID - 10.1371/journal.pone.0161174 [doi] PST - epublish SO - PLoS One. 2016 Aug 16;11(8):e0161174. doi: 10.1371/journal.pone.0161174. eCollection 2016.