An observational study in Recurrence of Clostridium Difficile Infection, sponsored by Ferring Pharmaceuticals. Completed at 42 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by Ferring Pharmaceuticals · Observational
This is a prospective observational cohort study designed to collect data on patients who received REBYOTA™ for the prevention of rCDI in the routine care setting. As all data collected for this study are observational, the decision to prescribe REBYOTA™ is at the treating physician's discretion and independent from the decision to enroll the patient in the study. Data will be collected from patients' medical records after obtaining informed consent. Data about clinical history, CDI events (primary and recurrent: severity, treatment), CDI-related symptoms, treatments, medical procedures, Adverse Events(AEs), and healthcare resource utilization (i.e., hospitalizations and re-admissions) will be collected through 6 months of follow-up from the date of REBYOTA™ administration.
Ferring Pharmaceuticals is the lead sponsor of 244 studies on the registry; 4 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 13 (93%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects who have received antibiotic treatment for Clostridioides Difficile Infection
Exclusion Criteria:
Drug: REBYOTA™
REBYOTA™ is administered in the rectum
Proportion of patients without Recurrence of Clostridioides Difficile Infection (rCDI) (as determined by the treating physician)
Time frame: 8 weeks after initial REBYOTA™ treatment
Proportion of patients with sustained clinical response, defined as treatment success of the presenting rCDI episode and no new CDI episodes occurring for more than 8 weeks through 6 months after initial REBYOTA™ treatment
Time frame: 6 months after initial REBYOTA™ treatment
Total number of CDI episodes
Time frame: 6 months after initial REBYOTA™ treatment
Time to any CDI episode
Time frame: 6 months after initial REBYOTA™ treatment
Daily mean changes in Clostridium difficile Infection-Daily Symptoms (CDIDaySyms™) scores from baseline to 7 days after REBYOTA™ administration
Time frame: 7 days after REBYOTA™ administration
Hospitalizations and re-admissions during follow-up for up to 6 months (all-cause and CDI-related) after receiving REBYOTA™
Time frame: Up to 6 months after receiving REBYOTA™
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Ferring Pharmaceuticals