Assessing live microbial therapeutic transmission

The development of fecal microbiota transplantation and defined live biotherapeutic products for the treatment of human disease has been an empirically driven process yielding a notable success of approved drugs for the treatment of recurrent Clostridioides difficile infection. Assessing the potenti...

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Main Author: Jeremiah J. Faith
Format: Article
Language:English
Published: Taylor & Francis Group 2025-12-01
Series:Gut Microbes
Subjects:
Online Access:https://www.tandfonline.com/doi/10.1080/19490976.2024.2447836
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author Jeremiah J. Faith
author_facet Jeremiah J. Faith
author_sort Jeremiah J. Faith
collection DOAJ
description The development of fecal microbiota transplantation and defined live biotherapeutic products for the treatment of human disease has been an empirically driven process yielding a notable success of approved drugs for the treatment of recurrent Clostridioides difficile infection. Assessing the potential of this therapeutic modality in other indications with mixed clinical results would benefit from consistent quantitative frameworks to characterize drug potency and composition and to assess the impact of dose and composition on the frequency and duration of strain engraftment. Monitoring these drug properties and engraftment outcomes would help identify minimally sufficient sets of microbial strains to treat disease and provide insights into the intersection between microbial function and host physiology. Broad and correct usage of strain detection methods is essential to this advancement. This article describes strain detection approaches, where they are best applied, what data they require, and clinical trial designs that are best suited to their application.
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spelling doaj-art-3903bf401f334e2d93cb2b5977b078a22025-01-03T04:00:53ZengTaylor & Francis GroupGut Microbes1949-09761949-09842025-12-0117110.1080/19490976.2024.2447836Assessing live microbial therapeutic transmissionJeremiah J. Faith0Precision Immunology Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USAThe development of fecal microbiota transplantation and defined live biotherapeutic products for the treatment of human disease has been an empirically driven process yielding a notable success of approved drugs for the treatment of recurrent Clostridioides difficile infection. Assessing the potential of this therapeutic modality in other indications with mixed clinical results would benefit from consistent quantitative frameworks to characterize drug potency and composition and to assess the impact of dose and composition on the frequency and duration of strain engraftment. Monitoring these drug properties and engraftment outcomes would help identify minimally sufficient sets of microbial strains to treat disease and provide insights into the intersection between microbial function and host physiology. Broad and correct usage of strain detection methods is essential to this advancement. This article describes strain detection approaches, where they are best applied, what data they require, and clinical trial designs that are best suited to their application.https://www.tandfonline.com/doi/10.1080/19490976.2024.2447836Microbiomestrain trackingmicrobial therapeuticsfecal microbiota transplantationlive biotherapeutic product
spellingShingle Jeremiah J. Faith
Assessing live microbial therapeutic transmission
Gut Microbes
Microbiome
strain tracking
microbial therapeutics
fecal microbiota transplantation
live biotherapeutic product
title Assessing live microbial therapeutic transmission
title_full Assessing live microbial therapeutic transmission
title_fullStr Assessing live microbial therapeutic transmission
title_full_unstemmed Assessing live microbial therapeutic transmission
title_short Assessing live microbial therapeutic transmission
title_sort assessing live microbial therapeutic transmission
topic Microbiome
strain tracking
microbial therapeutics
fecal microbiota transplantation
live biotherapeutic product
url https://www.tandfonline.com/doi/10.1080/19490976.2024.2447836
work_keys_str_mv AT jeremiahjfaith assessinglivemicrobialtherapeutictransmission