Validation methods for encapsulated faecal microbiota transplantation: a scoping review
Faecal microbiota transplantation (FMT) is increasingly used for diseases associated with a disrupted intestinal microbiome, mainly Clostridioides difficile infection. Encapsulated FMT is a patient-friendly application method that improves accessibility and convenience. Capsule processing may be sta...
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| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
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SAGE Publishing
2025-02-01
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| Series: | Therapeutic Advances in Gastroenterology |
| Online Access: | https://doi.org/10.1177/17562848251314820 |
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| _version_ | 1823865067496538112 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Nina Rågård |
| collection | DOAJ |
| description | Faecal microbiota transplantation (FMT) is increasingly used for diseases associated with a disrupted intestinal microbiome, mainly Clostridioides difficile infection. Encapsulated FMT is a patient-friendly application method that improves accessibility and convenience. Capsule processing may be standardised, but validation protocols are warranted. This review aimed to describe published validation methods for encapsulated FMT. Original studies reporting using encapsulated faecal formulations were included, regardless of indication. Studies were excluded if they did not address processing and validation or used non-donor-derived content. We conducted a comprehensive scoping review, implementing a systematic search strategy in PubMed, Embase and Web of Science. Processing data and validation methods were registered during full-text analysis and combined to create an overview of approaches for assessing quality in encapsulated FMT processing. The searches identified 324 unique studies, of which 44 were included for data extraction and analysis. We identified eight validation covariables: donor selection, pre-processing, preservation, oxygen-sparing processing, microbial count, viability, engraftment and clinical effect outcomes, from which we constructed a model for quality assessment of encapsulated FMT that exhaustively categorised processing details and validation measures. Our model comprised three domains: (1) Processing (donor selection and processing protocol), (2) Content analysis (microbiota measures and dose measures) and (3) Clinical effect (engraftment and clinical outcomes). No studies presented a reproducible capsule protocol; their validation strategies were sparse and divergent. The validation of FMT capsules is heterogeneous, and processing requires relevant standardisation protocols, mainly focusing on capsule content. Future studies should report validation covariables to enable accurate comparative assessments of clinical effects. |
| format | Article |
| id | doaj-art-425c7b9f4eb344e89bb24e25971dc40e |
| institution | Kabale University |
| issn | 1756-2848 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Therapeutic Advances in Gastroenterology |
| spelling | doaj-art-425c7b9f4eb344e89bb24e25971dc40e2025-02-08T11:03:26ZengSAGE PublishingTherapeutic Advances in Gastroenterology1756-28482025-02-011810.1177/17562848251314820Validation methods for encapsulated faecal microbiota transplantation: a scoping reviewNina RågårdSimon Mark Dahl BaumwallSara Ellegaard PaaskeMette Mejlby HansenKatrine Lundby HøyerSusan MikkelsenChristian ErikstrupJens Frederik DahlerupChristian Lodberg HvasFaecal microbiota transplantation (FMT) is increasingly used for diseases associated with a disrupted intestinal microbiome, mainly Clostridioides difficile infection. Encapsulated FMT is a patient-friendly application method that improves accessibility and convenience. Capsule processing may be standardised, but validation protocols are warranted. This review aimed to describe published validation methods for encapsulated FMT. Original studies reporting using encapsulated faecal formulations were included, regardless of indication. Studies were excluded if they did not address processing and validation or used non-donor-derived content. We conducted a comprehensive scoping review, implementing a systematic search strategy in PubMed, Embase and Web of Science. Processing data and validation methods were registered during full-text analysis and combined to create an overview of approaches for assessing quality in encapsulated FMT processing. The searches identified 324 unique studies, of which 44 were included for data extraction and analysis. We identified eight validation covariables: donor selection, pre-processing, preservation, oxygen-sparing processing, microbial count, viability, engraftment and clinical effect outcomes, from which we constructed a model for quality assessment of encapsulated FMT that exhaustively categorised processing details and validation measures. Our model comprised three domains: (1) Processing (donor selection and processing protocol), (2) Content analysis (microbiota measures and dose measures) and (3) Clinical effect (engraftment and clinical outcomes). No studies presented a reproducible capsule protocol; their validation strategies were sparse and divergent. The validation of FMT capsules is heterogeneous, and processing requires relevant standardisation protocols, mainly focusing on capsule content. Future studies should report validation covariables to enable accurate comparative assessments of clinical effects.https://doi.org/10.1177/17562848251314820 |
| spellingShingle | 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 Validation methods for encapsulated faecal microbiota transplantation: a scoping review Therapeutic Advances in Gastroenterology |
| title | Validation methods for encapsulated faecal microbiota transplantation: a scoping review |
| title_full | Validation methods for encapsulated faecal microbiota transplantation: a scoping review |
| title_fullStr | Validation methods for encapsulated faecal microbiota transplantation: a scoping review |
| title_full_unstemmed | Validation methods for encapsulated faecal microbiota transplantation: a scoping review |
| title_short | Validation methods for encapsulated faecal microbiota transplantation: a scoping review |
| title_sort | validation methods for encapsulated faecal microbiota transplantation a scoping review |
| url | https://doi.org/10.1177/17562848251314820 |
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