Prototype Biomarker Could Distinguish Healthy, Disruptive Gut Microbiota

The Microbiome Health Index for post-Antibiotic dysbiosis was developed to improve the understanding of and manage the risks associated with antibiotic administration.

A first-of-its-kind prototype biomarker from Ferring Pharmaceuticals and Rebiotix could distinguish post-antibiotic disruptions in human gut microbiota, known as dysbiosis, from healthy gut microbiota.

According to a press release, the Microbiome Health Index for post-Antibiotic dysbiosis (MHI-A) was developed to improve understanding about and manage the risks associated with antibiotic administration. It may help guide the development of live biotherapeutic products, which could be a potential new class of drugs, according to experts.

The gut microbiome is an incredibly diverse microbial community that is essential to human health, although antibiotics often disrupt the composition and diversity of the microbiome. This disruption is a risk factor for multiple serious illnesses, including C. difficile infection and potential recurrences.

Although the impact of antibiotic use on dysbiosis is documented, measuring dysbiosis is complex and approaches often vary between studies, leaving a need for a simple biomarker to identify gut microbiota composition and help support diagnostic decisions, according to the study.

“This biomarker provides a concise metric for assessing the complex changes in the microbiome of trial participants pre- to post-treatment, expanding our understanding of microbiome restoration after antibiotic use,” said lead author Ken Blount, PhD, chief scientific officer of Rebiotix and vice president of microbiome research at Ferring Pharmaceuticals, in the press release.

C. diff infection is a serious and potentially deadly disease in which bacteria cause debilitating symptoms, including severe diarrhea, fever, stomach tenderness or pain, loss of appetite, nausea, and colitis. It causes an estimated half-million illnesses and tens of thousands of annual deaths in the United States each year, and has been declared a public health threat by the CDC, requiring urgent and immediate action.

Infection with C. diff often causes a cycle of recurrences, with a significant burden for patients and the health care system. Up to 35% of C. diff cases recur after initial diagnosis, and individuals who have had a recurrence are at significantly higher risk of further infections. Restoring the gut microbiome is increasingly accepted as a promising treatment option for recurrent C. diff infection, according to the press release.

The MHI-A algorithm was designed to differentiate post-antibiotic dysbiosis from healthy microbiota. It does this using the relative abundances of bacteria that are naturally found in the gut microbiome and which are associated with health[DJ1] . According to the press release, the study found that MHI-A has high accuracy to distinguish post-antibiotic dysbiosis from healthy microbiota.

MHI-A was developed using longitudinal data from more than 200 treated patients across 3 controlled clinical trials with leading investigational microbiome-based live biotherapeutic products for the reduction of recurrent C. diff infection. It was validated using published data describing the microbiome of several healthy and antibiotic-treated populations.

The MHI-A values were consistent across multiple healthy populations and were significantly shifted by antibiotic treatments known to alter microbiota compositions. Furthermore, the values shifted less by microbiota-sparing antibiotics.

According to the press release, the researchers concluded the MHI-A is a promising biomarker of post-antibiotic dysbiosis and subsequent restoration. It may also be useful for rank-ordering the microbiota-disrupting impacts of antibiotics and as a pharmacodynamic measure of microbiota restoration.

REFERENCE

Frontiers in Microbiology publishes article detailing novel microbiome-based biomarker of post-antibiotic disruptions in gut microbiota. News release. Business Wire; January 7, 2022. Accessed January 13, 2022. https://www.businesswire.com/news/home/20220107005052/en/Frontiers-in-Microbiology-Publishes-Article-Detailing-Novel-Microbiome-based-Biomarker-of-Post-Antibiotic-Disruptions-in-Gut-Microbiota