UH Pharmacy professor's research reveals 'greater improvements' for battling superbug

A recent study led by University of Houston College of Pharmacy professor Kevin Garey has revealed promising results in the goal of improving the quality of life for medical patients suffering from recurrent Clostridium difficile (C. diff) infections, according to a news article published by UH on Jan. 31. 

According to the release, the study was centered on the effectiveness of SER-109, a microbiome therapeutic and live bacterial product designed to combat the persistent superbug. An SER-109 pill contains live, purified Firmicutes bacterial spores designed to metabolically compete with C. diff and restore the bacteria's colonization resistance. Among the wide array of known superbugs, or bacteria that have developed antibiotic resistances, C. diff is one of the most stubborn. Infection symptoms are both life-treating and capable of persisting for long periods, especially in those with recurrent disease.

“In this exploratory analysis patients treated with SER-109 had significantly greater improvements in health-related quality of life (HRQOL) scores compared to placebo-treated patients as early as Week 1, with continued steady and durable improvements by Week 8,” Garey wrote in the Journal of the American Medical Association (JAMA) Network Open. He also developed the disease-specific Quality of Life Survey (Cdiff32) measurement. “These findings suggest that an investigational microbiome therapeutic may improve HRQOL, an important patient-related outcome.”

A new medicine to combat C. diff is highly sought-after in the medical field. The superbug is the most common health care-associated infectious agent in the U.S. and is believed to cause more than 460,000 infections and 20,000 deaths annually. C. difficile infection (CDI) is a debilitating disease that typically causes between 10 to 20 watery bowel movements daily, leading to poor HRQOL, loss of productivity, anxiety, and depression.

“Currently approved antibiotics generally lead to symptom resolution through reduction of toxin-producing bacteria," Garey said. "However, sustained efficacy rates remain modest since antibiotics do not kill dormant C. difficile spores nor address the disrupted microbiome, the underlying cause of recurrent disease.”

SER-109's effectiveness in improving quality of life was tested in 182 adults with C. diff infections using a quality-of-life questionnaire originally developed by Garey and his colleagues.

Another positive finding from the study was the observed improvements in the mental domain and subdomain scores in the study's eighth week in patients taking SER-109 regardless of their clinical outcomes.

"Several interesting hypotheses arise from this novel observation, which may be related to the potential role of the microbiome in disorders related to the gut-brain axis," Garey said. "CDI is associated with a disrupted microbiome which has been associated with mood disorders, including anxiety and depression.”