REBYOTA™ Prospective Registry (ROAR)

January 26, 2026 updated by: Ferring Pharmaceuticals

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
145

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Ferring Investigational Site
    • California
      • Chula Vista, California, United States, 91910
        • Ferring Investigational Site
      • Murrieta, California, United States, 92563
        • Ferring Investigational Site
      • Oceanside, California, United States, 92054
        • Ferring Investigational Site
      • Sacramento, California, United States, 95816
        • Ferring Investigational Site
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Ferring Investigational Site
    • Florida
      • Gainesville, Florida, United States, 32610
        • Ferring Investigational Site
      • Orlando, Florida, United States, 32806
        • Ferring Investigational Site
      • Port Orange, Florida, United States, 32127
        • Ferring Investigational Site
      • Tampa, Florida, United States, 33614
        • Ferring Investigational Site
      • Zephyrhills, Florida, United States, 33542
        • Ferring Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Ferrin Investigational Site
      • La Grange, Georgia, United States, 30240
        • Ferring Investigational Site
      • Savannah, Georgia, United States, 31405
        • Ferring Investigational Site
    • Illinois
      • Burr Ridge, Illinois, United States, 60527
        • Ferring Investigational Site
      • Maywood, Illinois, United States, 60153
        • Ferring Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Ferring Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67211
        • Ferring Investigational Site
    • Louisiana
      • Jefferson, Louisiana, United States, 70121
        • Ferring Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Ferring Investigational Site
      • Worcester, Massachusetts, United States, 01608
        • Ferring Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Ferring Investigational Site
      • Detroit, Michigan, United States, 48202
        • Ferring Investigational Site
      • Farmington Hills, Michigan, United States, 48336
        • Ferring Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Ferring Investigational Site
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Ferring Investigational Site
    • New York
      • New York, New York, United States, 10016
        • Ferring Investigational Site
      • New York, New York, United States, 10021
        • Ferring Investigational Site
      • New York, New York, United States, 10279
        • Ferring Investigational Site
      • Rochester, New York, United States, 14618
        • Ferring Investigational Site
      • Stony Brook, New York, United States, 11794
        • Ferring Investigational Site
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • Ferring Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Ferring Investigational Site
      • Middleburg Heights, Ohio, United States, 44130
        • Ferring Investigational Site
    • Pennsylvania
      • DuBois, Pennsylvania, United States, 15801
        • Ferring Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15237
        • Ferring Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Ferring Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Ferring Investigational Site
    • Texas
      • Dallas, Texas, United States, 75246
        • Ferring Investigational Site
      • Houston, Texas, United States, 77030
        • Ferring Investigational Site
    • Utah
      • West Jordan, Utah, United States, 84088
        • Ferring Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Ferring Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects who have received antibiotic treatment for Clostridioides Difficile Infection

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
REBYOTA™
Drug: REBYOTA™
REBYOTA™ is administered in the rectum

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of patients without Recurrence of Clostridioides Difficile Infection (rCDI) (as determined by the treating physician)
Time Frame: 8 weeks after initial REBYOTA™ treatment
8 weeks after initial REBYOTA™ treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
6 months after initial REBYOTA™ treatment
Total number of CDI episodes
Time Frame: 6 months after initial REBYOTA™ treatment
6 months after initial REBYOTA™ treatment
Time to any CDI episode
Time Frame: 6 months after initial REBYOTA™ treatment
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
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™
Up to 6 months after receiving REBYOTA™

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ferring Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 19, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 29, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 29, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 000422

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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