According to results published in Open Forum Infectious Diseases, patients receiving biotherapeutic therapy with fecal microbiota, live-jslm for recurrent Clostridioides difficile infection (CDI) experience substantial and sustained improvement in disease-specific health-related quality of life (HRQOL).
Researchers in the United States and Canada conducted a randomized, double-blinded, placebo-controlled phase 3 trial to evaluate HRQOL in patients with recurrent CDI. Eligible patients were adults receiving antibiotics for CDI-related diarrhea control at the time of enrollment. Patients were randomly assigned 2:1 to receive either 1 dose of biotherapeutic therapy with fecal microbiota, live-jslm (intervention) or normal saline (placebo). At enrollment and weeks 1, 4, and 8, HRQOL was evaluated using Cdiff32, a validated, disease-specific survey designed to quantify changes in HRQOL across physical, mental, and social domains.
The researchers compared HRQOL between patients in the intervention and placebo groups during a follow-up period of up to 8 weeks. Multivariable linear regression was used to compare changes in Cdiff32 scores between the groups. Adjustments were made for potential confounders, including sex, age, number of prior CDI episodes, prior receipt of fidaxomicin, prior proton pump inhibitor use, and indicators of common comorbidities.
The post hoc analysis included a total of 128 patients in the intervention group and 57 in the placebo group, of whom the mean ages were 60.8 and 57 years, 68.08% and 71.9% were women, and the mean number of prior CDI episodes were 3.2 and 3, respectively.
Both total and individual domain scores of Cdiff32 were assessed on a 100-point scale, with 0 as the worst and 100 as the best score. Total Cdiff32 scores were similar between patients in the intervention vs placebo groups at baseline (mean [SD] score, 44.2 [17.5] vs 43.6 [21.3]).
The researchers observed significant increases in total Cdiff32 scores for patients in both groups throughout the study period, indicating improvements in HRQOL (P <.001). Between baseline and week 8, the overall mean (SD) changes in score (6.0 [3.4]) was higher among patients in the intervention group (31.6 [21.4]) compared with those in the placebo group (25.6 [21.4]). In addition, the adjusted analyses indicated that the between-group difference in total scores at week 8 was significant and favored patients in the intervention group (7.2; 95% CI, 1.2-13.2; P <.05).
Similar results were observed for physical, mental, and social domains, with Cdiff32 scores for each increasing among all patients between baseline and week 8. Adjusted analyses at week 8 indicated significantly greater improvement in physical (6.6; 95% CI, 0.8-12.3; P <.05) and mental (8.3; 95% CI, 1.4-15.3; P <.05) domain scores among intervention recipients compared with placebo recipients.
Patients without CDI recurrence at week 8 were considered responders. Both the change in total and domain scores between baseline and week 8 indicated significant improvement in HRQOL among responders in both groups. Although adjusted analyses showed improvement in both total Cdiff32 and individual domain scores among responders in the intervention vs placebo groups, only improvement in the mental domain score was significant (7.4; 95% CI, 0.3-14.4; P <.05).
Limitations of this study include potentially limited generalizability, the small sample size of nonresponders, and missing data for some patients.
According to the researchers, “Our findings indicated that live biotherapeutic products such as RBL [fecal microbiota, live-jslm] can positively affect patients’ HRQL providing comprehensive benefit in the treatment of rCDI.”
Disclosures: Multiple study authors declared affiliations with pharmaceutical, biotech, and/or device companies. Please see the original reference for a full list of disclosures.
Garey KW, Dubberke ER, Guo A, et al. Effect of fecal microbiota, live-jslm (RBL) on health-related quality of life in patients with recurrent Clostridioides difficile infection: results from the PUNCH CD3 clinical trial. Open Forum Infect Dis. Published online July 20, 2023. doi:10.1093/ofid/ofad383