Open forum infectious diseases · 2025
Decreased Antimicrobial Resistance Gene Richness Following Fecal Microbiota, Live-jslm (REBYOTA®) Administration: Post Hoc Analysis of PUNCH CD3.
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Adamowicz Elizabeth, Kraft Colleen S, Ward Tonya, Mehta Nirja, Shannon William D, Mishra Rohan, Blount Ken F
Аннотация
BACKGROUND: The human gastrointestinal microbiome helps maintain vital functions related to overall health, including resistance to pathogen colonization. Disruption of the microbiome, leading to loss of colonization resistance, can be caused by multiple factors, including antimicrobial use. The loss of colonization resistance may lead to establishment or proliferation of opportunistic bacteria that carry genes associated with antimicrobial resistance, potentially increasing the risk of infection by such antimicrobial-resistant bacteria. A potential approach to mitigating this risk involves restoration of healthier microbiota and pathogen colonization resistance.
METHODS: A metagenomic sequencing method was used to conduct a post hoc analysis of antibiotic resistance gene richness among fecal samples from participants administered fecal microbiota, live-jslm (REBYOTA; abbreviated as RBL) or placebo in the PUNCH CD3 study (NCT03244644) for the prevention of recurrent Clostridioides difficile infection.
RESULTS: At baseline, participants had higher antibiotic resistance gene richness than a representative healthy cohort. Over time, RBL responders had lower antibiotic resistance gene richness at the class, group, and mechanism levels as compared with placebo responders. These differences were evident as early as 1 week after administration and sustained for at least 6 months. RBL responders also had decreased richness of antibiotic resistance genes deemed high risk based on designated bacterial public health threats.
CONCLUSIONS: These data support a model in which microbiota-based products, including RBL, may reduce antibiotic resistance gene richness, thereby possibly reducing the risk of antimicrobial-resistant organism infection.
TRIAL REGISTRATION: NCT03244644 (https://clinicaltrials.gov/study/NCT03244644; 9 August 2017).
METHODS: A metagenomic sequencing method was used to conduct a post hoc analysis of antibiotic resistance gene richness among fecal samples from participants administered fecal microbiota, live-jslm (REBYOTA; abbreviated as RBL) or placebo in the PUNCH CD3 study (NCT03244644) for the prevention of recurrent Clostridioides difficile infection.
RESULTS: At baseline, participants had higher antibiotic resistance gene richness than a representative healthy cohort. Over time, RBL responders had lower antibiotic resistance gene richness at the class, group, and mechanism levels as compared with placebo responders. These differences were evident as early as 1 week after administration and sustained for at least 6 months. RBL responders also had decreased richness of antibiotic resistance genes deemed high risk based on designated bacterial public health threats.
CONCLUSIONS: These data support a model in which microbiota-based products, including RBL, may reduce antibiotic resistance gene richness, thereby possibly reducing the risk of antimicrobial-resistant organism infection.
TRIAL REGISTRATION: NCT03244644 (https://clinicaltrials.gov/study/NCT03244644; 9 August 2017).