Analyzing the Microbiome After Live Biotherapeutic Product Treatment


Investigators explored the makeup of antibiotic resistant genes after administration of the live biotherapeutic product, Rebyota (fecal microbiota, Live-jslm), to see what differences would be discovered.

What You Should Know

The study found that the administration of Rebyota was associated with significant decreases in various antibiotic resistance genes, including extended spectrum beta-lactamases (ESBLs), fluoroquinolone resistance, and colistin resistance.

The study observed that the clinical efficacy of Rebyota correlated with an increase in the relative abundance of certain bacterial classes, specifically Bacteroidia and Clostridia, which are associated with a healthy gut microbiome.

The potential for microbiome-based therapies to offer alternative treatment options for infectious diseases.

It has been theorized that the administration of live biotherapeutic products (LBP) may help to decolonize patients of bacteria that carry antibiotic resistance genes (ARGs). A new study demonstrated the effects of a live biotherapeutic product on patients’ gut microbiome after it was administered. It has been nearly a year now since Ferring's LBP Rebyota (fecal microbiota, Live-jslm) was FDA approved for recurrent Clostridioides difficile Infection, and the company has been involved in multiple continuing studies.

In one of their studies, they examined patients who had been administered Rebyota and looked at their microbiome. This was a double-blind, placebo-controlled, phase 3 trial, titled PUNCH CD3.

The study was developed into a poster, Analysis of Antimicrobial Resistance Genes in Patients With Recurrent Clostridioides difficile Infection Following Fecal Microbiota, Live-jslm (REBYOTA) Administration, and presented at the recent World AMR Congress.

After completing antibiotic therapy for the enrolling CDI episode, participants received a single, blinded dose of Rebyota or placebo. As an exploratory analysis, participants were asked to provide stool samples before (baseline) and at several timepoints after assigned study treatment.

According to the study's authors, Rebyota’s clinical efficacy correlated with increases in the relative abundance of Bacteroidia and Clostridia, 2 bacterial classes associated with a healthy microbiome.

“Really the key takeaways that we saw were significant decreases from before to after treatment. And those ARG's included extended-spectrum beta-lactamases, fluoroquinolone resistance—even colistin resistance we found in patients was decreased from before to after treatment. And all of those decreases tended to be significantly more in Rebyota treated compared to placebo treated patients,” explains lead study author Ken Blount, PhD, chief scientific officer for Rebiotix, and Ferring vice president, Microbiome Research.

Blount believes their might be future potential clinical applications for microbiome-based therapies.

“Antibiotics have been tremendous; they've been incredibly powerful, but we now recognize they can have side effects that involve dysbiosis in the gut, and can involve building up and harboring resistance,” Blount said. “So thinking about that and the way you consider antibiotics, and moving forward to think about nontraditional antibiotic options like the microbiome to address infectious diseases. I think that's where we're really hoping the community's mindset continues to shift over the years.”

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