NCT05835219

REBYOTA™ Prospective Registry

REBYOTA™ for the Prevention of Recurrence of Clostridioides Difficile Infection (CDI) in Adult Patients: An Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 145 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Recurrence of Clostridium Difficile Infection

Interventions

Type	Name	Description
DRUG	REBYOTA™	REBYOTA™ is administered in the rectum

Timeline

• Start date: 2023-06-19
• Primary completion: 2025-08-29
• Completion: 2025-08-29
• First posted: 2023-04-28
• Last updated: 2026-01-28

Locations

42 sites across 1 country: United States

Regulatory

• FDA-regulated drug study