Adverse events in fecal microbiota transplantation: a systematic review and meta-analysis

Abstract

Background Fecal microbiota transplantation (FMT) is a highly efficacious procedure used most commonly for the treatment of recurrent Clostridioides difficile infection (CDI). Despite the high value of incorporating FMT into practice, there remain concerns about its safety. To the best of our knowledge, there has not been an updated meta-analysis reporting pooled rates of adverse events in FMT for CDI. Methods A search for studies of FMT in patients with CDI was performed with the rate of serious adverse events (SAEs) related to FMT evaluated as the primary outcome. Secondary outcomes included SAEs unrelated to FMT and minor adverse events associated with FMT. A pooled analysis was then performed. Results Initial search identified 378 reference articles. Data were extracted from the 61 of these studies that met the inclusion criteria, comprising 5099 patients. Pooled analysis showed that SAEs related to FMT developed in less than 1% of patients. The pooled rate of SAEs not related to FMT was higher at 2.9%. The pooled rate of minor adverse events also showed infrequent self-limited gastrointestinal and systemic discomfort. Conclusions This meta-analysis supports FMT as a safe option for treating recurrent CDI. Future randomized trials are needed to improve our current understanding of FMT safety and further examine the improvements in the quality of life of patients treated with FMT compared to standard therapy of antibiotics.

VE303, a Defined Bacterial Consortium, for Prevention of Recurrent Clostridioides difficile Infection

“…No treatment-related serious TEAEs or deaths were reported. The favorable tolerability profile of VE303 was expected, based on prior reports of fecal microbiota transplants and other live biotherapeutic products …”

Trasplante de microbiota fecal por colonoscopía en paciente mayor de 65 años con infección recurrente de Clostridioides difficile: aún una estrategia subutilizada

“…Este caso muestra que el TMF puede ser una técnica segura y eficaz en el tratamiento de la ICD recurrente en este grupo de pacientes. Un metaanálisis que incluyó 61 estudios (5.099 pacientes), mostró que el TMF es una técnica segura con escasos eventos adversos, generalmente leve a moderados y autolimitados 14 . La ausencia de eventos adversos en nuestro paciente post-TMF muestra que esta es una estrategia válida en pacientes mayores de 65 años, tal como ha sido señalado en otra publicación nacional 13 .…”

The gut microbiome dysbiosis and regulation by fecal microbiota transplantation: umbrella review

“…In patients with CDI receiving FMT, an earlier meta-analysis found overall disease recurrence rates of 5.5% (95% CI, 2.2-10.3%), with early (<90 days) recurrence of 2.9% (95% CI, 0.009-0.058%) and late (≥90 days) recurrence of 1.7% (95% CI, 0.4-4.2%; Figure 10A). Total severe adverse events were 0.65% (95% CI, 0.45-0.89%; Supplementary Table S2; Rapoport et al, 2022). Antibiotic use was associated with most recurrences.…”