The vast majority of microbiome studies failed to address core methodological aspects including the use of anaerobic conditions, sample volume, storage etc. with a lack of protocol normalization and standardization (1).
Following the agreement of an EU-wide approach in relation to the classification of FMT, regulatory guidance and standards for FMT will need to be developed to provide assurance in relation to quality, efficacy and safety. Aspects to be addressed would include standards to be applied during processing and storage (2).
At Microviable we recommend GutAlive®, the unique anaerobic stool collection device that ensures the microbiota sample viability, preserving the original composition and diversity of the microbiome creating an anaerobic atmosphere. Using GutAlive® for stool sampling and transport enables higher recovery of anaerobic bacteria than any other device, by limiting oxygen exposure during the whole process (European Consensus Conference on FMT recommends anaerobic storage and processing if possible) (3).
Standardizing sample collection and transport of the fecal specimens, GutAlive® can be applied to set up the basis of protocol normalization in microbiota-based studies (4), enabling downstream applications including FMT, microbiome analysis and bacterial isolation.
- Guidelines For Reporting On Animal Faecal Transplantation (GRAFT) Studies: Recommendations From A Systematic Review of Murine Transplantation Protocols
- Faecal Microbiota Transplantation. EU-IN Horizon Scanning Report
- European consensus conference on faecal microbiota transplantation in clinical practice
- Use of an anaerobic stool collection device and its impact on the standardization of downstream microbiota-based studies