Encapsulated donor faeces for faecal microbiota transplantation: the Glyprotect protocol

Mette Mejlby Hansen; Nina Rågård; Pia Winther Andreasen; Sara Ellegaard Paaske; Jens Frederik Dahlerup; Susan Mikkelsen; Christian Erikstrup; Simon Mark Dahl Baunwall; Christian Lodberg Hvas

doi:10.1177/17562848241289065

Encapsulated donor faeces for faecal microbiota transplantation: the Glyprotect protocol

Mette Mejlby Hansen, Nina Rågård, Pia Winther Andreasen, Sara Ellegaard Paaske, Jens Frederik Dahlerup, Susan Mikkelsen, Christian Erikstrup, Simon Mark Dahl Baunwall, Christian Lodberg Hvas

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

3 Citations (Scopus)

Abstract

BACKGROUND: Faecal microbiota transplantation (FMT) is a highly effective treatment for Clostridioides difficile infection. Its use is backed by solid evidence, but application methods differ. Encapsulated FMT is a non-invasive, patient-friendly and scalable application method that may be preferred over colonoscopy or nasoduodenal tube application.

OBJECTIVES: We describe a detailed protocol, the Glyprotect protocol, for producing glycerol-based capsules to increase FMT accessibility.

DESIGN: Using iterative quality improvement methods, we developed and validated the Glyprotect protocol as a reproducible protocol for cryopreserving minimally processed donor faeces in a standard hospital laboratory setting.

METHODS: We describe detailed standard operating procedures for producing glycerol-based capsules, including all necessary materials and troubleshooting guidelines. Capsule integrity was tested at various temperatures and pH levels. Flow cytometry was used to measure microbiota counts and dose accuracy.

RESULTS: The Glyprotect protocol has been used for more than 2500 capsule-based FMT treatments and complies with European tissue and cell standards. The protocol is optimised to preserve microbes and minimise modulation of the donated microbiota by removing debris and water, which also reduces the number of capsules needed per FMT treatment. The intestinal microbiota is preserved in glycerol for cryoprotection and to prevent capsule leakage. Each capsule contains 650 µL microbe-glycerol mass, estimated to contain an average of 2.5 × 10 8 non-specified bacteria.

CONCLUSION: The Glyprotect protocol enables hospitals and tissue establishments to set up capsule production in a standard laboratory, improving patients' access to FMT. The protocol facilitates the scalability of FMT services because capsule FMT is less time-consuming and less expensive than liquid-suspension FMT applied by colonoscopy or nasojejunal tube.

TRIAL REGISTRATION: Not applicable.

Original language	English
Journal	Therapeutic Advances in Gastroenterology
Volume	17
Pages (from-to)	17562848241289065
ISSN	1756-283X
DOIs	https://doi.org/10.1177/17562848241289065
Publication status	Published - 14 Oct 2024

Keywords

Clostridioides difficile
capsules
clinical laboratory techniques
faecal microbiota transplantation
laboratory manual [publication type]
medical laboratory personnel
microbiology
patient safety

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10.1177/17562848241289065Licence: CC BY-NC-ND

Cite this

@article{28b097286314416789ac16c701cda8e8,

title = "Encapsulated donor faeces for faecal microbiota transplantation: the Glyprotect protocol",

abstract = "BACKGROUND: Faecal microbiota transplantation (FMT) is a highly effective treatment for Clostridioides difficile infection. Its use is backed by solid evidence, but application methods differ. Encapsulated FMT is a non-invasive, patient-friendly and scalable application method that may be preferred over colonoscopy or nasoduodenal tube application. OBJECTIVES: We describe a detailed protocol, the Glyprotect protocol, for producing glycerol-based capsules to increase FMT accessibility.DESIGN: Using iterative quality improvement methods, we developed and validated the Glyprotect protocol as a reproducible protocol for cryopreserving minimally processed donor faeces in a standard hospital laboratory setting.METHODS: We describe detailed standard operating procedures for producing glycerol-based capsules, including all necessary materials and troubleshooting guidelines. Capsule integrity was tested at various temperatures and pH levels. Flow cytometry was used to measure microbiota counts and dose accuracy.RESULTS: The Glyprotect protocol has been used for more than 2500 capsule-based FMT treatments and complies with European tissue and cell standards. The protocol is optimised to preserve microbes and minimise modulation of the donated microbiota by removing debris and water, which also reduces the number of capsules needed per FMT treatment. The intestinal microbiota is preserved in glycerol for cryoprotection and to prevent capsule leakage. Each capsule contains 650 µL microbe-glycerol mass, estimated to contain an average of 2.5 × 10 8 non-specified bacteria. CONCLUSION: The Glyprotect protocol enables hospitals and tissue establishments to set up capsule production in a standard laboratory, improving patients' access to FMT. The protocol facilitates the scalability of FMT services because capsule FMT is less time-consuming and less expensive than liquid-suspension FMT applied by colonoscopy or nasojejunal tube.TRIAL REGISTRATION: Not applicable.",

keywords = "Clostridioides difficile, capsules, clinical laboratory techniques, faecal microbiota transplantation, laboratory manual [publication type], medical laboratory personnel, microbiology, patient safety",

author = "Hansen, {Mette Mejlby} and Nina R{\aa}g{\aa}rd and Andreasen, {Pia Winther} and Paaske, {Sara Ellegaard} and Dahlerup, {Jens Frederik} and Susan Mikkelsen and Christian Erikstrup and Baunwall, {Simon Mark Dahl} and Hvas, {Christian Lodberg}",

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language = "English",

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Encapsulated donor faeces for faecal microbiota transplantation: the Glyprotect protocol. / Hansen, Mette Mejlby ; Rågård, Nina; Andreasen, Pia Winther et al.
In: Therapeutic Advances in Gastroenterology, Vol. 17, 14.10.2024, p. 17562848241289065.

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

TY - JOUR

T1 - Encapsulated donor faeces for faecal microbiota transplantation

T2 - the Glyprotect protocol

AU - Hansen, Mette Mejlby

AU - Rågård, Nina

AU - Andreasen, Pia Winther

AU - Paaske, Sara Ellegaard

AU - Dahlerup, Jens Frederik

AU - Mikkelsen, Susan

AU - Erikstrup, Christian

AU - Baunwall, Simon Mark Dahl

AU - Hvas, Christian Lodberg

PY - 2024/10/14

Y1 - 2024/10/14

N2 - BACKGROUND: Faecal microbiota transplantation (FMT) is a highly effective treatment for Clostridioides difficile infection. Its use is backed by solid evidence, but application methods differ. Encapsulated FMT is a non-invasive, patient-friendly and scalable application method that may be preferred over colonoscopy or nasoduodenal tube application. OBJECTIVES: We describe a detailed protocol, the Glyprotect protocol, for producing glycerol-based capsules to increase FMT accessibility.DESIGN: Using iterative quality improvement methods, we developed and validated the Glyprotect protocol as a reproducible protocol for cryopreserving minimally processed donor faeces in a standard hospital laboratory setting.METHODS: We describe detailed standard operating procedures for producing glycerol-based capsules, including all necessary materials and troubleshooting guidelines. Capsule integrity was tested at various temperatures and pH levels. Flow cytometry was used to measure microbiota counts and dose accuracy.RESULTS: The Glyprotect protocol has been used for more than 2500 capsule-based FMT treatments and complies with European tissue and cell standards. The protocol is optimised to preserve microbes and minimise modulation of the donated microbiota by removing debris and water, which also reduces the number of capsules needed per FMT treatment. The intestinal microbiota is preserved in glycerol for cryoprotection and to prevent capsule leakage. Each capsule contains 650 µL microbe-glycerol mass, estimated to contain an average of 2.5 × 10 8 non-specified bacteria. CONCLUSION: The Glyprotect protocol enables hospitals and tissue establishments to set up capsule production in a standard laboratory, improving patients' access to FMT. The protocol facilitates the scalability of FMT services because capsule FMT is less time-consuming and less expensive than liquid-suspension FMT applied by colonoscopy or nasojejunal tube.TRIAL REGISTRATION: Not applicable.

AB - BACKGROUND: Faecal microbiota transplantation (FMT) is a highly effective treatment for Clostridioides difficile infection. Its use is backed by solid evidence, but application methods differ. Encapsulated FMT is a non-invasive, patient-friendly and scalable application method that may be preferred over colonoscopy or nasoduodenal tube application. OBJECTIVES: We describe a detailed protocol, the Glyprotect protocol, for producing glycerol-based capsules to increase FMT accessibility.DESIGN: Using iterative quality improvement methods, we developed and validated the Glyprotect protocol as a reproducible protocol for cryopreserving minimally processed donor faeces in a standard hospital laboratory setting.METHODS: We describe detailed standard operating procedures for producing glycerol-based capsules, including all necessary materials and troubleshooting guidelines. Capsule integrity was tested at various temperatures and pH levels. Flow cytometry was used to measure microbiota counts and dose accuracy.RESULTS: The Glyprotect protocol has been used for more than 2500 capsule-based FMT treatments and complies with European tissue and cell standards. The protocol is optimised to preserve microbes and minimise modulation of the donated microbiota by removing debris and water, which also reduces the number of capsules needed per FMT treatment. The intestinal microbiota is preserved in glycerol for cryoprotection and to prevent capsule leakage. Each capsule contains 650 µL microbe-glycerol mass, estimated to contain an average of 2.5 × 10 8 non-specified bacteria. CONCLUSION: The Glyprotect protocol enables hospitals and tissue establishments to set up capsule production in a standard laboratory, improving patients' access to FMT. The protocol facilitates the scalability of FMT services because capsule FMT is less time-consuming and less expensive than liquid-suspension FMT applied by colonoscopy or nasojejunal tube.TRIAL REGISTRATION: Not applicable.

KW - Clostridioides difficile

KW - capsules

KW - clinical laboratory techniques

KW - faecal microbiota transplantation

KW - laboratory manual [publication type]

KW - medical laboratory personnel

KW - microbiology

KW - patient safety

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U2 - 10.1177/17562848241289065

DO - 10.1177/17562848241289065

M3 - Journal article

C2 - 39421003

SN - 1756-283X

VL - 17

SP - 17562848241289065

JO - Therapeutic Advances in Gastroenterology

JF - Therapeutic Advances in Gastroenterology

ER -

Encapsulated donor faeces for faecal microbiota transplantation: the Glyprotect protocol

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