Assessment of Quality of Life Among Patients With Recurrent Clostridioides difficile Infection Treated with Investigational Oral Microbiome Therapeutic SER-109

Abstract

ImportanceRecurrent Clostridioides difficile infection (CDI) is a debilitating disease leading to poor health-related quality of life (HRQOL), loss of productivity, anxiety, and depression. The potential association of treatment with HRQOL has not been well evaluated.ObjectivesTo explore the association of SER-109 compared with placebo on HRQOL in patients with recurrent CDI up to week 8.Design, Setting, and ParticipantsThis study was a secondary analysis of a randomized, double-blind, placebo-controlled trial that took place at 56 sites in the US and Canada from July 2017 to April 2020 and included 182 patients randomized to SER-109 or placebo groups.InterventionsSER-109 or placebo (4 capsules once daily for 3 days) following antibiotics for CDI.Main Outcomes and MeasuresExploratory analysis of HRQOL using the disease specific Clostridioides difficile Quality of Life Survey (Cdiff32) assessed at baseline, week 1, and week 8.ResultsIn this study, 182 patients (109 [59.9%] female; mean age, 65.5 [16.5] years) were randomized to SER-109 (89 [48.9%]) or placebo (93 [51.1%]) groups and were included in the primary and exploratory analyses. Baseline Cdiff32 scores were similar between patients in the SER-109 and placebo groups (52.0 [18.3] vs 52.8 [18.7], respectively). The proportion of patients with overall improvement from baseline in the Cdiff32 total score was higher in the SER-109 arm than placebo at week 1 (49.4% vs 26.9%; P = .012) and week 8 (66.3% vs 48.4%; P = .001).Greater improvements in total and physical domain and subdomain scores were observed in patients in the SER-109 group compared with placebo as early as week 1, with continued improvements observed at week 8. Among patients in the placebo group, improvements in HRQOL were primarily observed in patients with nonrecurrent CDI while patients in the SER-109 group reported improvements in HRQOL, regardless of clinical outcome.Conclusions and RelevanceIn this secondary analysis of a phase 3 clinical trial, SER-109, an investigational microbiome therapeutic was associated with rapid and steady improvement in HRQOL compared with placebo through 8 weeks, an important patient-reported outcome.Trial RegistrationClinicalTrials.gov Identifier: NCT03183128

Efficacy and Practical Implementation of Fecal Microbiota Spores, Live-BRPK: A Novel Approach for Preventing Recurrent Clostridioides difficile Infection

“…The assessment of quality-of-life data is intriguing. Within the placebo cohort, most of the improvements were seen in the group that did not recur, as one might expect, but, interestingly, there were trends for improvement in the group that received VOS regardless of whether they recurred or not (21). Understanding the broader impact of administration of Firmicutes spores may provide valuable insights into their mechanisms of action and potential applications in managing other healthrelated factors although further assessment is required.…”

Efficacy and Health-Related Quality of Life Impact of Fecal Microbiota, Live-jslm: A Post Hoc Analysis of PUNCH CD3 Patients at First Recurrence of Clostridioides difficile Infection

“…Per trial protocol, treatment success at week 8 was defined by the absence of C. difficile associated diarrhea (without the need for retreatment as assessed by subject interview and physical exam). HRQL was measured during the double-blind period using the C. diff Health-related Quality-of-Life Questionnaire (Cdiff32) [ 29 , 30 ], a validated, disease-specific survey that quantifies HRQL including a total score and three domain scores (physical, mental, and social). Cdiff32 comprises 32 self-administered questions about the impact of CDI, with each question offering five responses on a Likert-scale indicating how a person is affected by CDI-related concerns in the past 7 days (see Supplementary Material for the questionnaire).…”

Error in Visual Abstract

“…In the Original Investigation titled “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” 1 published January 30, 2023, there was a mistake in the Visual Abstract. In the Findings section, the labels for the placebo and SER-109 were inadvertently transposed.…”

“…In the Findings section, the labels for the placebo and SER-109 were inadvertently transposed. This article has been corrected …”