SER-109, an investigational microbiome agent, significantly improves health-related quality of life (HRQOL) in patients with recurrent Clostridioides difficile infection (CDI), according to study findings published in JAMA Network Open.
The aim of this secondary analysis of a multicenter, randomized, placebo-controlled study was to compare HRQOL outcomes in patients with recurrent CDI who were randomized to receive either SER-109 or placebo. Included patients (N=182) were those with 3 or more CDI episodes within the previous 12 months, including the qualifying episode. All patients received standard-of-care antibiotics prior to treatment allocation. Researchers assessed health-related QOL at baseline and at weeks 1 and 8 using the disease-specific Clostridioides difficile Quality of Life Survey (Cdiff32).
Among patients included in the SER-109 (n=89) and placebo (n=95) groups, the mean (SD) age was 65.5 (15.5) years, 59.9% were women, 93.4% were White, 94% were non-Hispanic, and 98.9% were outpatients.
Although Cdiff32 scores were similar between groups at baseline, significantly more patients in the SER-109 group demonstrated improvement in total Cdiff32 scores at week 1 compared with those in the placebo group (49% vs 27%; P =.012). The higher percentage of patients in the SER-109 vs placebo groups demonstrating overall improvement in Cdiff32 scores was more significant at week 8 (66% vs 48%; P =.001).
Greater improvement in physical domain and subdomain scores also were observed among patients in the SER-109 group compared with those in the placebo group. Improvement in HRQOL was primarily observed among patients in the SER-109 group with recurrent CDI, whereas improvement in HRQOL among patients in the placebo group was primarily observed in those with nonrecurrent CDI.
Study limitations include the inability to confirm whether HRQOL improvements were due to sustained clinical response or other factors. Also, because baseline estimates of HRQOL were determined after clinical resolution via antibiotic therapy, the ability to observe the full spectrum of improvement after the qualifying episode may have been limited.
According to the researchers, “These data suggest that an investigational microbiome therapeutic not only offers the clinical benefits of reduced CDI recurrence, but may also improve HRQOL…”
Garey KW, Jo J, Gonzales-Luna AJ, et al. Assessment of quality of life among patients with recurrent Clostridioides difficile infection treated with investigational oral microbiome therapeutic SER-109: secondary analysis of a randomized clinical trial. JAMA Netw Open. 2023;6(1):e2253570. doi:10.1001/jamanetworkopen.2022.53570