Table 3.
Cdiff32 Domain | Difference in Cdiff32 Score, Point Estimateb (95% CI) (n = 185c) | P Value |
---|---|---|
Total | 7.2 (1.2–13.2) | <.05 |
Physical | 6.6 (.8–12.3) | <.05 |
Mental | 8.3 (1.4–15.3) | <.05 |
Social | 6.5 (−.6 to 13.6) | .08 |
Abbreviations: Cdiff32, Clostridioides difficile Health-related Quality-of-Life Survey; CI, confidence interval; RBL, fecal microbiota, live-jslm (REBYOTA; Rebiotix).
The analyses included the following baseline covariates: respective baseline Cdiff32 score, treatment group, sex, age (in years), number of C difficile episodes before treatment, treatment with fidaxomicin, proton pump inhibitor use, metabolism and nutrition disorders, surgical and medical procedures, infections and infestations, gastrointestinal disorders, and psychiatric disorders.
The point estimates represent improvement in Cdiff32 total or domain score in patients given RBL versus placebo.
Sample sizes for the as-observed analysis differed across domain scores according to data availability.