REBYOTA™ Prospective Registry

Completed

Conditions studied: Recurrence of Clostridium Difficile Infection

In brief

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.

Key facts

Study ID

NCT05835219

Run by

Ferring Pharmaceuticals

People needed

145

Starts

2023-06-19

Expected to finish

2025-08-29

Last updated by the study team

2026-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed and dated informed consent form (ICF)
• Age ≥ 18 years
• Diagnosis of rCDI as determined by the treating physician
• Completed antibiotic treatment for the presenting rCDI episode
• Prescription for REBYOTA™ to prevent rCDI according to the approved indication

You may not qualify if…

• Currently enrolled in an interventional clinical trial

Where it is running

• Ferring Investigational Site — Chandler, Arizona, United States
• Ferring Investigational Site — Chula Vista, California, United States
• Ferring Investigational Site — Murrieta, California, United States
• Ferring Investigational Site — Oceanside, California, United States
• Ferring Investigational Site — Sacramento, California, United States
• Ferring Investigational Site — Hamden, Connecticut, United States
• Ferring Investigational Site — Gainesville, Florida, United States
• Ferring Investigational Site — Orlando, Florida, United States
• Ferring Investigational Site — Port Orange, Florida, United States
• Ferring Investigational Site — Tampa, Florida, United States
• Ferring Investigational Site — Zephyrhills, Florida, United States
• Ferrin Investigational Site — Atlanta, Georgia, United States
• Ferring Investigational Site — La Grange, Georgia, United States
• Ferring Investigational Site — Savannah, Georgia, United States
• Ferring Investigational Site — Burr Ridge, Illinois, United States
• Ferring Investigational Site — Maywood, Illinois, United States
• Ferring Investigational Site — Iowa City, Iowa, United States
• Ferring Investigational Site — Wichita, Kansas, United States
• Ferring Investigational Site — Jefferson, Louisiana, United States
• Ferring Investigational Site — Boston, Massachusetts, United States
• Ferring Investigational Site — Worcester, Massachusetts, United States
• Ferring Investigational Site — Detroit, Michigan, United States
• Ferring Investigational Site — Detroit, Michigan, United States
• Ferring Investigational Site — Farmington Hills, Michigan, United States
• Ferring Investigational Site — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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