REBYOTA™ Prospective Registry

NCT ID: NCT05835219

Last Updated: 2026-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

145 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-19

Study Completion Date

2025-08-29

Brief Summary

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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.

Detailed Description

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Conditions

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Recurrence of Clostridium Difficile Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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REBYOTA™

REBYOTA™

Intervention Type DRUG

REBYOTA™ is administered in the rectum

Interventions

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REBYOTA™

REBYOTA™ is administered in the rectum

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Compliance

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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Ferring Investigational Site

Chandler, Arizona, United States

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Chula Vista, California, United States

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Murrieta, California, United States

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Oceanside, California, United States

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Sacramento, California, United States

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Hamden, Connecticut, United States

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Gainesville, Florida, United States

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Orlando, Florida, United States

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Port Orange, Florida, United States

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Tampa, Florida, United States

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Zephyrhills, Florida, United States

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Ferrin Investigational Site

Atlanta, Georgia, United States

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La Grange, Georgia, United States

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Savannah, Georgia, United States

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Burr Ridge, Illinois, United States

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Maywood, Illinois, United States

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Iowa City, Iowa, United States

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Wichita, Kansas, United States

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Jefferson, Louisiana, United States

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Boston, Massachusetts, United States

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Worcester, Massachusetts, United States

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Detroit, Michigan, United States

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Detroit, Michigan, United States

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Farmington Hills, Michigan, United States

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Omaha, Nebraska, United States

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Teaneck, New Jersey, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Stony Brook, New York, United States

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Fargo, North Dakota, United States

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Cincinnati, Ohio, United States

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Middleburg Heights, Ohio, United States

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DuBois, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Knoxville, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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West Jordan, Utah, United States

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Charlottesville, Virginia, United States

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Countries

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United States

Other Identifiers

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000422

Identifier Type: -

Identifier Source: org_study_id

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