Validation methods for encapsulated faecal microbiota transplantation: a scoping review

Nina Rågård; Simon Mark Dahl Baumwall; Sara Ellegaard Paaske; Mette Mejlby Hansen; Katrine Lundby Høyer; Susan Mikkelsen; Christian Erikstrup; Jens Frederik Dahlerup; Christian Lodberg Hvas

doi:10.1177/17562848251314820

Validation methods for encapsulated faecal microbiota transplantation: a scoping review

Nina Rågård, Simon Mark Dahl Baumwall, Sara Ellegaard Paaske, Mette Mejlby Hansen, Katrine Lundby Høyer, Susan Mikkelsen, Christian Erikstrup, Jens Frederik Dahlerup, Christian Lodberg Hvas^*

^*Corresponding author for this work

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Review › Research › peer-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.

Original language	English
Journal	Therapeutic Advances in Gastroenterology
Volume	18
Number of pages	25
ISSN	1756-283X
DOIs	https://doi.org/10.1177/17562848251314820
Publication status	Published - 1 Jan 2025

Keywords

capsules administration and dosage
faecal microbiota transplantation methods
faeces
humans
microbiology
validation studies

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10.1177/17562848251314820Licence: CC BY

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title = "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.",

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doi = "10.1177/17562848251314820",

language = "English",

volume = "18",

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Validation methods for encapsulated faecal microbiota transplantation: a scoping review. / Rågård, Nina; Baumwall, Simon Mark Dahl; Paaske, Sara Ellegaard et al.
In: Therapeutic Advances in Gastroenterology, Vol. 18, 01.01.2025.

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Review › Research › peer-review

TY - JOUR

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T2 - a scoping review

AU - Rågård, Nina

AU - Baumwall, Simon Mark Dahl

AU - Paaske, Sara Ellegaard

AU - Hansen, Mette Mejlby

AU - Høyer, Katrine Lundby

AU - Mikkelsen, Susan

AU - Erikstrup, Christian

AU - Dahlerup, Jens Frederik

AU - Hvas, Christian Lodberg

PY - 2025/1/1

Y1 - 2025/1/1

N2 - 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.

AB - 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.

KW - capsules administration and dosage

KW - faecal microbiota transplantation methods

KW - faeces

KW - humans

KW - microbiology

KW - validation studies

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VL - 18

JO - Therapeutic Advances in Gastroenterology

JF - Therapeutic Advances in Gastroenterology

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Validation methods for encapsulated faecal microbiota transplantation: a scoping review

Abstract

Keywords

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