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Observational study on REBYOTA™ for preventing recurrent Clostridium Difficile Infection

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

Ferring Pharmaceuticals · NCT05835219

This study looks at how well REBYOTA™ works to prevent repeat Clostridium Difficile infections in patients who have received it during their regular medical care.

Quick facts

Study typeObservational
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorFerring Pharmaceuticals (industry)
Locations42 sites (Chandler, Arizona and 41 other locations)
Trial IDNCT05835219 on ClinicalTrials.gov

What this trial studies

This observational cohort study aims to gather data on patients who have received REBYOTA™ to prevent recurrent Clostridium Difficile Infection (rCDI) in a routine care setting. The prescribing of REBYOTA™ is at the discretion of the treating physician, and patient enrollment is independent of this decision. Data will be collected from medical records after obtaining informed consent, focusing on clinical history, CDI events, symptoms, treatments, adverse events, and healthcare resource utilization over a 6-month follow-up period post-administration of REBYOTA™.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with recurrent CDI and have completed antibiotic treatment for their current episode.

Not a fit: Patients currently enrolled in an interventional clinical trial may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of REBYOTA™ in preventing recurrent CDI, potentially improving patient outcomes.

How similar studies have performed: While this study is observational, similar approaches in other studies have shown promise in understanding treatment outcomes for recurrent CDI.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Chandler, Arizona and 41 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Recurrence of Clostridium Difficile Infection

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.