title: Systematic Review: Adverse Events of Fecal Microbiota Transplantation.
abstract: 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.
  
  
  OBJECTIVE
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China.
authors.forename: Sinan
authors.initials: S
authors.lastname: Wang
authors.affiliation: Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China.
authors.forename: Mengque
authors.initials: M
authors.lastname: Xu
authors.affiliation: Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China.
authors.forename: Weiqiang
authors.initials: W
authors.lastname: Wang
authors.affiliation: Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China.
authors.forename: Xiaocang
authors.initials: X
authors.lastname: Cao
authors.affiliation: Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China.
authors.forename: Meiyu
authors.initials: M
authors.lastname: Piao
authors.affiliation: Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China.
authors.forename: Samiullah
authors.initials: S
authors.lastname: Khan
authors.affiliation: Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China.|Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN 37232, United States of America.
authors.forename: Fang
authors.initials: F
authors.lastname: Yan
authors.affiliation: Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China.|Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN 37232, United States of America.
authors.forename: Hailong
authors.initials: H
authors.lastname: Cao
authors.affiliation: Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China.
authors.forename: Bangmao
authors.initials: B
authors.lastname: Wang
mesh_terms: D000069467:Fecal Microbiota Transplantation / Q000009:adverse effects*; D006801:Humans; D012449:Safety