200 Participants Needed

REBYOTA™ Prospective Registry

(ROAR Trial)

Recruiting at 38 trial locations
GC
Overseen ByGlobal Clinical Compliance
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ferring Pharmaceuticals
Must be taking: Antibiotics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial collects data on patients who received REBYOTA™ to prevent repeated gut infections. It targets those with recurrent Clostridioides difficile infections and works by restoring healthy bacteria in the intestines. REBYOTA™ is used to restore healthy bacteria in the intestines, with cure rates of about 87% in treating recurrent Clostridioides difficile infections.

Research Team

GC

Global Clinical Compliance

Principal Investigator

Ferring Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

Signed and dated informed consent form (ICF)
Diagnosis of rCDI as determined by the treating physician
Completed antibiotic treatment for the presenting rCDI episode
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

Treatment

Participants receive REBYOTA™ for the prevention of recurrent Clostridioides Difficile Infection (rCDI)

Follow-up

Data about clinical history, CDI events, symptoms, treatments, medical procedures, Adverse Events, and healthcare resource utilization are collected through 6 months of follow-up

6 months

Treatment Details

Interventions

  • REBYOTA™
Participant Groups
1Treatment groups
Experimental Treatment
Group I: REBYOTA™Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ferring Pharmaceuticals

Lead Sponsor

Trials
323
Recruited
1,242,000+
Pierre-Yves Berclaz profile image

Pierre-Yves Berclaz

Ferring Pharmaceuticals

Chief Medical Officer since 2023

MD from the University of Lausanne, PhD in Molecular Biology from the Cincinnati College of Medicine

Jean-Frédéric Paulsen profile image

Jean-Frédéric Paulsen

Ferring Pharmaceuticals

Chief Executive Officer since 2023

Master’s degree in Finance from the London School of Economics and Political Science

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