A University of Houston-led team reporting in JAMA Network Open presents findings from a secondary analysis of data collected for a Phase 3 randomized clinical trial centered on an oral microbiome therapeutic-based approach for improving the quality of life in individuals plagued with recurrent Clostridioides difficile infections (CDI). With data for 182 clinical trial participants randomized to receive an investigational oral microbiome drug known as SER-109 or placebo between 2017 and spring of 2020 at sites in the US and Canada, the investigators performed a secondary, exploratory analysis focused on health-related quality of life scores (HRQOL) that brought in 32 physical, mental, and social measures at baseline, after one week of treatment, or after eight weeks. Their results reveal HRQOL improvements for individuals receiving SER-109 that were not present in the placebo group. "These data suggest that an investigational microbiome therapeutic not only offers the clinical benefits of reduced CDI recurrence," the authors write, "but may also improve HRQOL, an important patient-reported outcome of great interest to patients, clinicians, payers, and regulators."
Health-Related Quality of Life Gets Boost After Microbiome-Based Treatment for Recurrent C. Diff
Jan 31, 2023