Systematic Review With Meta-analysis

Review of Donor Features, Procedures and Outcomes in 168 Clinical Studies of Faecal Microbiota Transplantation

Cheuk Yin Lai; Joanne Sung; Felix Cheng; Whitney Tang; Sunny H. Wong; Paul K.S. Chan; Michael A. Kamm; Joseph J.Y. Sung; Gilaad Kaplan; Francis K.L. Chan; Siew C. Ng


Aliment Pharmacol Ther. 2019;49(4):354-363. 

In This Article

Abstract and Introduction


Background: Faecal microbiota transplantation (FMT) is effective for Clostridium difficile infections (CDI) refractory to standard treatment and is being studied in other diseases.

Aim: To evaluate donor characteristics, procedures and clinical outcomes of FMT.

Methods: We systematically reviewed FMT studies published up to 29 August 2018 using MEDLINE (R) and EMBASE and identified clinical studies with FMT donor information. We reported data on donor characteristics, screening criteria, administration, clinical outcomes and adverse events.

Results: Among 5267 reports, 239 full-text articles were screened and 168 articles were included. FMT was performed commonly for CDI (n = 108) and inflammatory bowel disease (IBD) (n = 31). We reported characteristics of 1513 donors [58% male; mean age, 34.3 years; mean body mass index, 21.6]. Donors in Asia were younger than the West (mean age 30.7 vs 32.9, P = 0.00075). Less than 50% of studies screened donors for transmittable pathogens. Final cure rate for CDI was 95.6% (95% confidence interval [CI], 93.9%-97.1%) and final remission rates for ulcerative colitis (UC) and Crohn's disease (CD) were 39.6% (95% CI, 25.4%-54.6%) and 47.5% (95% CI, 29.4%-65.8%), respectively. Cure rates in CDI and final remission rates for CD and UC were comparable across all routes of FMT administration. Overall adverse event incidence was <1%, mostly GI-related. Adverse event rates did not differ significantly between routes of FMT administration or indication.

Conclusions: In a systematic review assessing donor characteristics and FMT efficacy, we observed heterogeneity in donor selection, application and outcomes of FMT. These data can facilitate standardisation of FMT protocols for various diseases.


Faecal microbiota transplantation (FMT) involves the engraftment of the gut microbiota of healthy individuals into diseased recipients to reconstitute a normal intestinal microbial composition. It is currently been used to treat recurrent and refractory Clostridium difficileinfections worldwide (CDI).[1,2] There is also increasing investigation into other conditions such as inflammatory bowel disease (IBD), irritable bowel syndrome, obesity, acute graft-versus-host diseases and autism.[3–7] The United States Food and Drug Administration has approved that investigational new drug (IND) application is not required for the use of FMT for treatment of recurrent CDI but except for stool banks distributing stool to physicians.[8]Recent frameworks have promoted the need of easy access for patients to FMT as well as efficacy and safety data for regulators and providers. However, research in FMT beyond the indication of CDI remains limited.[9]

Importantly, standardised FMT procedures are lacking, particularly on donor characteristics and selection. Although International recommendations exist for FMT, they are rarely implemented rigorously in practice.[10] Several meta-analyses have reported data on the efficacy and safety of FMT for CDI but few have analysed donor characteristics or microbial profile.[2,11–16] Even widely used protocols have highly variable donor selection methods which are mostly limited to screening for infections and co-morbidities.[17–19] We performed a systematic review of all FMT clinical studies without language restriction up to 29 August 2018. This review comprehensively examined donor characteristics and screening protocols as well as FMT procedures and outcomes.