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Validation methods for encapsulated faecal microbiota transplantation: a scoping review

Nina Rågård1, Simon Mark Dahl Baumwall1, Sara Ellegaard Paaske1,2

  • 1Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.

Therapeutic Advances in Gastroenterology
|February 10, 2025
PubMed

Insights

Encapsulated faecal microbiota transplantation (FMT) offers a convenient way to treat microbiome-disrupting diseases. However, current validation methods for FMT capsules are inconsistent, highlighting a need for standardized processing and quality assessment protocols.

Area of Science:

  • Microbiology
  • Gastroenterology
  • Pharmacology

Background:

  • Faecal microbiota transplantation (FMT) is a key therapy for intestinal microbiome dysbiosis, particularly *Clostridioides difficile* infection.
  • Encapsulated FMT enhances patient accessibility and convenience compared to traditional methods.
  • Standardized processing and robust validation protocols are crucial for encapsulated FMT efficacy and safety.

Purpose of the Study:

  • To systematically review and describe published validation methods for encapsulated FMT.
  • To identify key covariables and domains for assessing the quality of encapsulated FMT processing.
  • To highlight the heterogeneity in current validation strategies and propose a quality assessment model.

Main Methods:

  • A comprehensive scoping review was conducted using systematic searches in PubMed, Embase, and Web of Science.
  • Studies reporting on encapsulated faecal formulations, including processing and validation, were included.
  • Data on processing and validation methods were extracted and analyzed to develop a quality assessment model.

Main Results:

  • Forty-four studies were included, identifying eight critical validation covariables: donor selection, pre-processing, preservation, oxygen-sparing processing, microbial count, viability, engraftment, and clinical outcomes.
  • A three-domain model for quality assessment was constructed: Processing, Content Analysis, and Clinical Effect.
  • No studies presented a reproducible capsule protocol, and validation strategies were found to be sparse and divergent.

Conclusions:

  • The validation of FMT capsules is currently heterogeneous, necessitating the development of standardized processing protocols, with a focus on capsule content.
  • A comprehensive quality assessment model encompassing processing, content analysis, and clinical effect is proposed.
  • Future research should prioritize reporting of validation covariables to facilitate comparative assessments of encapsulated FMT clinical effects.
Keywords:
capsules administration and dosagefaecal microbiota transplantation methodsfaeceshumansmicrobiologyvalidation studies

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