Multi-donor Fecal Microbial Transplantation for Critically Ill Patients: Rationale and Standard Operating Procedure
Abstract
Patients in intensive care unit often lose a considerable fraction of their gut microbiome due to exposure of broad-spectrum antibiotics and other reasons. Dysbiosis often results in prolonged diarrhea and increase occurrence of multi-drug resistant pathogens in the colon with clinical consequences not yet well understood. Restoring the microbioma by faecal microbial transplantation (FMT) is a plausible therapeutic possibility, so far only documented in case reports and case series using very heterogeneous methodologies. Before FMT in critically ill can be tested in randomised controlled trials, there is a burning need to describe a standardized operating procedure (SOP) of the whole process, respecting the specifics of critically ill population, such as the risk of disrubted intestinal barrier and time critical nature of the procedure. We describe the SOP that has been developed for experimental use in critically ill patients by a multidisciplinary team of intensivists, gastroenterologist and microbiologist based on feedback from regulatory authority (State Institue of Drug Control of the Czech Republic). The hallmarks of these SOPs are multi-donor freshly frozen transplantate quaranteeded for 3 months consisting of 7 aliqutes from 7 unrelated healthy donors, and administered by rectal tube. In this paper we discuss the rationale for this SOP and the process of its development in details and release the full proposed SOP is in the form of online appendix.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
Read the paper
Related studies
- Bile Acid 7α-Dehydroxylating Gut Bacteria Secrete Antibiotics that Inhibit Clostridium difficile: Role of Secondary Bile Acids
- Ketogenic diet alleviates colitis by reduction of colonic group 3 innate lymphoid cells through altering gut microbiome
- Altered gut microbiome composition and function are associated with gut barrier dysfunction in healthy relatives of patients with Crohn's disease
- Diet, obesity, and the gut microbiome as determinants modulating metabolic outcomes in a non-human primate model
- Immune Impairment Associated with Vitamin A Deficiency: Insights from Clinical Studies and Animal Model Research
- Glyphosate-based herbicides influence antioxidants, reproductive hormones and gut microbiome but not reproduction: A long-term experiment in an avian model
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.