Faecal microbiota transplantation: a safe procedure to treat recurrent Clostridium difficile infections

A meta-analysis of patients receiving treatment for Clostridium difficile infection showed that faecal microbiota transplantation is generally a safe procedure, with the most significant adverse events being unrelated to the intervention. The majority of adverse events observed were minor and were commonly abdominal pain, constipation, nausea, and vomiting. 

Despite the efficacy of faecal microbiota transplantation (FMT), the procedure is still highly underutilised, probably due to concerns over its safety. To shed light on this issue, Dr Eliot A. Rapoport (University of Illinois College of Medicine, IL, USA) and colleagues performed a meta-analysis including 61 unique original research studies on FMT for Clostridium difficile infections (CDI) [1].

The literature search was conducted using MEDLINE through PubMed, Ovid, Cochrane Library, and EMBASE from 2015 to 2021. Published articles written in English or with English translation were eligible for inclusion if they reported the use and outcomes of FMT for the management of CDI in the non-paediatric population. They extracted data on rates of adverse events (AEs), the primary target of interest being the rate of significant adverse events (SAEs) related to FMT.

Of the 378 reference articles identified by the initial search, 61 studies met the inclusion criteria, with data from 5,099 patients receiving 5,551 transplantations. An upper gastrointestinal route was specified in 30% of the cases and a lower gastrointestinal route in 56%. 4.8% of patients had IBD, and 8.0% were immunosuppressed.

Despite a significant proportion of patients being immunocompromised, the overall rate of SAEs related to FMT was only 0.65% (95% CI 0.45–0.89; P<0.01). Harbord-Egger bias indicator showed that there was no publication bias. The most commonly reported SAEs were sepsis, aspiration pneumonia, and bowel perforation. The rate of SAEs deemed unrelated to FMT was higher at 2.9% (95% CI 2.47–3.39). This finding was to be expected because FMT was often reserved for extremely ill patients. However, minor adverse events were common but were mostly self-limited gastrointestinal discomforts such as abdominal pain, constipation, nausea, and vomiting.

The meta-analysis demonstrated that FMT is generally a safe procedure for CDI with significant adverse events noted in less than 1% of the patients. Dr Rapoport stated, "our current knowledge of related SAEs and unrelated SAEs indicates that FMT should be a therapy strongly considered for patients with recurrent CDI."

Further studies should evaluate the role played by route of administration and immunosuppression on FMT efficacy and safety to improve the present knowledge and to ascertain the improvements in the quality of life of patients treated with FMT compared with those who have undergone standard antibiotic therapy.

1. Rapoport EA, et al. Adverse events in fecal microbiota transplantation: a systematic review and meta-analysis. Poster Su1602, Digestive Disease Week 2022, 21–24 May, San Diego, CA, USA.

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Posted on 14 June 202227 March 2024