FMT in IBS: a call for caution

ABSTRACT

Correspondence to Professor Michael Camilleri, Mayo Clinic, Rochester, MN 55905, USA;camilleri.michael@mayo.edu In addition to the excellent commentary1 accompanying the very intriguing randomised controlled trial on the efficacy of faecal microbial transplantation (FMT) from a single super donor in patients with irritable bowel syndrome (IBS) by El-Salhy et al,2 allow me to provide additional insights on efficacy and safety that call for caution in applying FMT to the treatment of IBS. [...]for most months of the study, at least 25% of patients on either 30 g or 60 g FMT had severe symptoms (score >300) based on the data in table 2.2 With reference to safety, around 20% of the patients in the FMT group reported adverse effects of abdominal pain, cramping or tenderness, diarrhoea or constipation, in contrast to an average 2% in those on placebo. [...]two patients developed diverticulitis compared with none on placebo. On 12 March 2020, the US Food and Drug Administration (FDA) issued a warning of potential risk for serious infections due to FMT caused by enteropathogenic or Shigatoxin-producing E. coli that have occurred following investigational use of an FMT product supplied by a stool bank (from pre-screened donors).6 Moreover, there was another FDA safety alert regarding use of faecal microbiota for transplantation and additional safety protections pertaining to severe acute respiratory syndrome coronavirus 2 and COVID-19.7 This is a plea for caution in the application of FMT for IBS, an essentially benign disorder.