Validation methods for encapsulated faecal microbiota transplantation: a scoping review

Abstract

A comprehensive evaluation of quality aspects to consider when developing encapsulated donor faeces for faecal microbiota transplantation Faecal microbiota transplantation (FMT) is a life-saving therapy, based on the transfer of intestinal microbiota from a healthy donor to a patient to treat disease. Encapsulation of donor faeces eases the application of FMT, but methods to evaluate the quality of encapsulated FMT are not standardised. Based on a systematic literature review, we here provide a comprehensive overview of factors that may influence the quality of encapsulated FMT. We describe three main domains that together form a model for standardisation: 1. Processing (donor selection and processing protocol), 2. Content analysis (microbiota measures and dose measures) and 3. Clinical effect (engraftment and clinical outcomes). These domains may be addressed in future studies that report the use of encapsulated FMT.