Efficacy and safety of fecal microbiota transplantation for the treatment of diseases other than Clostridium difficile infection: a systematic review and meta-analysis

Gut Microbes. 2020 Nov 9;12(1):1-25. doi: 10.1080/19490976.2020.1854640.


The intestinal microbiome has been identified as a key modifier for a variety of health conditions. Fecal Microbiota Transplantation (FMT) has emerged as a fast, safe, and effective means by which to modify the intestinal microbiome and potentially treat a variety of health conditions. Despite extensive research of FMT for CDI, there is a lack of clarity informed by systematic synthesis of data regarding the safety and efficacy of FMT for other health conditions. This systematic review used PRISMA guidelines and was prospectively registered with PROSPERO (CRD42018104243). In March 2020, a search of MEDLINE, EMBASE, and PsycINFO was conducted. We identified 26 eligible studies. A meta-analysis of FMT for active Ulcerative Colitis (UC) showed that FMT significantly improved rates of clinical remission (OR = 3.634, 95% CI = 1.940 to 6.808, I2 = 0%, p < .001), clinical response (OR = 2.634, 95% CI = 1.441 to 4.815, I2 = 33%, p = .002) and endoscopic remission (OR = 4.431, 95% CI = 1.901 to 10.324, I2 = 0%, p = .001). With respect to Irritable Bowel Syndrome, a meta-analysis showed no significant change in symptoms following FMT (p = .739). Hepatic disorders, metabolic syndrome, and antibiotic-resistant organisms were conditions with emerging data on FMT. Serious adverse events (AE) were more often reported in control group participants (n = 43) compared with FMT group participants (n = 26). There were similar rates of mild to moderate AE in both groups. Preliminary data suggest that FMT is a potentially safe, well-tolerated and efficacious treatment for certain conditions other than CDI, with evidence for active UC being the most compelling.

Keywords: Fecal microbiota transplantation clostridium difficile; RCT; depression; irritable bowel syndrome; mental disorder; meta-analysis; microbiome; neuroscience; psychiatry; systematic review; ulcerative colitis.

Publication types

  • Meta-Analysis
  • Research Support, Non-U.S. Gov't
  • Systematic Review

MeSH terms

  • Colitis, Ulcerative / therapy*
  • Drug Resistance, Bacterial / genetics
  • Fecal Microbiota Transplantation / adverse effects
  • Fecal Microbiota Transplantation / methods*
  • Gastrointestinal Microbiome / physiology
  • Humans
  • Irritable Bowel Syndrome / therapy*
  • Liver Diseases / therapy*
  • Metabolic Syndrome / therapy*
  • Obesity / therapy*
  • Treatment Outcome

Grants and funding

No funding was received for this work.