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.
ABSTRACT
The available COVID-19 literature has focused on specific disease manifestations, infection control, and delivery or prioritization of services for specific patient groups in the setting of the acute COVID-19 pandemic. Local health systems aim to contain the COVID-19 pandemic and hospitals and health-care providers rush to provide the capacity for a surge of COVID-19 patients. However, the short, medium-term, and long-term outcomes of patients with gastrointestinal (GI) diseases without COVID-19 will be affected by the ability to develop locally adapted strategies to meet their service needs in the COVID-19 setting. To mitigate risks for patients with GI diseases, it is useful to differentiate three phases: (i) the acute phase, (ii) the adaptation phase, and (iii) the consolidation phase. During the acute phase, service delivery for patients with GI disease will be curtailed to meet competing health-care needs of COVID-19 patients. During the adaptation phase, GI services are calibrated towards a "new normal," and the consolidation phase is characterized by rapid introduction and ongoing refinement of services. Proactive planning with engagement of relevant stakeholders including consumer representatives is required to be prepared for a variety of scenarios that are dictated by thus far undefined long-term economic and societal impacts of the pandemic. Because substantial changes to the delivery of services are likely to occur, it is important that these changes are embedded into quality and research frameworks to ensure that data are generated that support evidence-based decision-making during the adaptation and consolidation phases.