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Microbiota Restoration and LBPs
The Future of CDI Recurrence Prevention?

Released: September 25, 2023

Paul Feuerstadt
Paul Feuerstadt, MD, FACG, AGAF
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Key Takeaways

On Friday, October 13, 2023, I will be part of a symposium at IDWeek 2023 in Boston, Massachusetts, focused on the importance of microbiota restoration and how best to incorporate live biotherapeutic products into complex Clostridioides difficile management approaches. I invite you to read more about this topic below and then register to hear more at the live interactive symposium, either in person or virtually.

Urgent Health Threat
The CDC classifies C. difficile as an urgent health threat. It is the most common healthcare-associated infection and results in a massive burden on our patient population and healthcare system.

One of the biggest challenges associated with this infection is recurrence. It is estimated that up to 35% of patients who are treated with guideline-based management for initial infection will have their infection recur. Among those patients, 45% will have their infection recur after that, and 60% thereafter, as patients get caught in this challenging cycle of repeated episodes of diarrhea. Any therapy that can decrease rates of recurrence following the initial antimicrobial treatment is welcomed.

The Microbiota and Recurrence of C. difficile
There are 2 phases of C. difficile infection: the vegetative phase and spore phase. The vegetative phase causes the symptoms that patients experience and is managed with standard-of-care antimicrobials such as vancomycin or fidaxomicin.

In the spore phase, C. difficile typically remains within a patient’s body following antimicrobial therapy, and it is this phase that reconverts to the vegetative phase, causing a recurrence.

A healthy diverse microbiota helps to eradicate the spore phase, but following antimicrobial therapy, the microbiota is in its least diverse state. Without further intervention, natural microbiota regrowth is needed to restore those deficiencies. If the microbiota is unable to do that successfully, the spore phase reconverts to the vegetative and a recurrence occurs.

Microbiota restoration therapy is a technique used to supplement deficiencies in the microbiota that otherwise might be unable to regrow. This treatment, after antimicrobial therapy for C. difficile, is associated with decreased rates of recurrence.

This technique was previously referred to as “fecal microbiota transplantation” or FMT, a rudimentary—albeit effective—method to supplement the deficiencies.

With a more sophisticated understanding of the microbiota, pharmaceutical companies have created new standardized products, called live biotherapeutic products (LBP), that can help restore the microbiota, using FDA-approved therapies, with data supported by FDA-overseen clinical trials.

FMT vs LBP
FMT was a very effective method for supplementing the microbiota when we did not have access to FDA-approved therapies.

The differences between FMT and LBPs are many, including quality of the clinical trial designs, heterogeneity of outcome assessment, safety assessment of donors, and the product themselves. Of most importance, LBPs have proprietary consortia of microorganisms that are being administered to patients.

With FMT, the safety of the donor and the material being given was analyzed, but there was no quantification of the microbial consortium that was being delivered. LBPs have undergone extensive safety and efficacy assessments and, given the proprietary consortia associated with their product, should have a more predictable outcome profile in clinical practice.

LBPs
In November of 2022 and April of 2023, 2 LBPs were separately approved by the FDA.

One, fecal microbiota, live-JSLM, is a rectally administered broad consortium of microorganisms given as a single dose in a healthcare professional’s office following treatment with a standard-of-care antimicrobial.

The other, fecal microbiota spores, live-BRPK, is an encapsulated form of Firmicutes spores derived from donor stool. This is administered as 4 capsules daily for 3 days following a bowel purge with magnesium citrate.

FDA approval of both products has opened up these treatments to many healthcare professionals who were otherwise uncomfortable using the investigational FMT. To me, the LBPs are the future for the prevention of recurrence of C. difficile infection.

We will explore more about LBPs and microbiota restoration at our interactive panel discussion–based symposium at IDWeek 2023. You can join us in person or by live webcast to hear a patient advocate and expert faculty provide perspectives and recommendations on the importance of microbiota restoration and how best to incorporate LBPs into complex C. difficile management approaches.

Your thoughts?
Have you tried using LBPs for your patients? Are you comfortable using an LBP if you have a patient who is indicated for this? Join the discussion by posting a comment.