REBYOTA™ Prospective Registry

NCT05835219 | Completed FDA Drug

• 1 other identifier: 000422
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 42

Brief 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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients without Recurrence of Clostridioides Difficile Infection (rCDI) (as determined by the treating physician)

  8 weeks after initial REBYOTA™ treatment

Secondary Outcomes (5)

• 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

  6 months after initial REBYOTA™ treatment

• Total number of CDI episodes

  6 months after initial REBYOTA™ treatment

• Time to any CDI episode

  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

  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™

  Up to 6 months after receiving REBYOTA™

Study Arms (1)

REBYOTA™

Drug: REBYOTA™

Interventions

REBYOTA™ DRUG

REBYOTA™ is administered in the rectum

REBYOTA™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who have received antibiotic treatment for Clostridioides Difficile Infection

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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (42)

Ferring Investigational Site

Chandler, Arizona, 85224, United States

Location

Ferring Investigational Site

Chula Vista, California, 91910, United States

Location

Ferring Investigational Site

Murrieta, California, 92563, United States

Location

Ferring Investigational Site

Oceanside, California, 92054, United States

Location

Ferring Investigational Site

Sacramento, California, 95816, United States

Location

Ferring Investigational Site

Hamden, Connecticut, 06518, United States

Location

Ferring Investigational Site

Gainesville, Florida, 32610, United States

Location

Ferring Investigational Site

Orlando, Florida, 32806, United States

Location

Ferring Investigational Site

Port Orange, Florida, 32127, United States

Location

Ferring Investigational Site

Tampa, Florida, 33614, United States

Location

Ferring Investigational Site

Zephyrhills, Florida, 33542, United States

Location

Ferrin Investigational Site

Atlanta, Georgia, 30322, United States

Location

Ferring Investigational Site

La Grange, Georgia, 30240, United States

Location

Ferring Investigational Site

Savannah, Georgia, 31405, United States

Location

Ferring Investigational Site

Burr Ridge, Illinois, 60527, United States

Location

Ferring Investigational Site

Maywood, Illinois, 60153, United States

Location

Ferring Investigational Site

Iowa City, Iowa, 52242, United States

Location

Ferring Investigational Site

Wichita, Kansas, 67211, United States

Location

Ferring Investigational Site

Jefferson, Louisiana, 70121, United States

Location

Ferring Investigational Site

Boston, Massachusetts, 02115, United States

Location

Ferring Investigational Site

Worcester, Massachusetts, 01608, United States

Location

Ferring Investigational Site

Detroit, Michigan, 48201, United States

Location

Ferring Investigational Site

Detroit, Michigan, 48202, United States

Location

Ferring Investigational Site

Farmington Hills, Michigan, 48336, United States

Location

Ferring Investigational Site

Omaha, Nebraska, 68198, United States

Location

Ferring Investigational Site

Teaneck, New Jersey, 07666, United States

Location

Ferring Investigational Site

New York, New York, 10016, United States

Location

Ferring Investigational Site

New York, New York, 10021, United States

Location

Ferring Investigational Site

New York, New York, 10279, United States

Location

Ferring Investigational Site

Rochester, New York, 14618, United States

Location

Ferring Investigational Site

Stony Brook, New York, 11794, United States

Location

Ferring Investigational Site

Fargo, North Dakota, 58122, United States

Location

Ferring Investigational Site

Cincinnati, Ohio, 45267, United States

Location

Ferring Investigational Site

Middleburg Heights, Ohio, 44130, United States

Location

Ferring Investigational Site

DuBois, Pennsylvania, 15801, United States

Location

Ferring Investigational Site

Pittsburgh, Pennsylvania, 15237, United States

Location

Ferring Investigational Site

Charleston, South Carolina, 29425, United States

Location

Ferring Investigational Site

Knoxville, Tennessee, 37909, United States

Location

Ferring Investigational Site

Dallas, Texas, 75246, United States

Location

Ferring Investigational Site

Houston, Texas, 77030, United States

Location

Ferring Investigational Site

West Jordan, Utah, 84088, United States

Location

Ferring Investigational Site

Charlottesville, Virginia, 22903, United States

Location

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: April 28, 2023
• Study Start: June 19, 2023
• Primary Completion: August 29, 2025
• Study Completion: August 29, 2025
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (42)