Completed

NCT Number: NCT05835219

REBYOTA™ Prospective Registry

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.

Completed

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Key information

Conditions

Recurrence of Clostridium Difficile Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ferring Investigational Site, Chandler, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Currently enrolled in an interventional clinical trial

Treatment and study plan

REBYOTA™

Drug

REBYOTA™ is administered in the rectum

Primary outcomes

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

Time frame: 8 weeks after initial REBYOTA™ treatment

Secondary outcomes

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™

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: ROAR

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Apr 28, 2023
Registry last updated: Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.