A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection

Completed · Phase 3

Conditions studied: Clostridium Difficile Infection Recurrence

In brief

This trial will be initiated to explore whether RBX2660 (REBYOTA®) could be suitable for administration by the practice of colonoscopy. More specifically, the purpose of this trial is to explore the safety and clinical effectiveness of RBX2660 when delivered by colonoscopy to adults with rCDI. The experience of physicians will be documented through a physician-experience questionnaire to explore the usability of RBX2660 in clinical practice for colonoscopic administration. Furthermore, to explore the patient-experience of RBX2660 treatment, each trial participant will be offered to undergo a structured interview.

Key facts

Study ID

NCT05831189

Run by

Ferring Pharmaceuticals

People needed

41

Starts

2023-04-21

Expected to finish

2025-01-17

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• have documented evidence of rCDI (≥1 recurrence after a primary CDI episode)
• be undergoing antibiotic treatment for the qualifying rCDI episode that was diagnosed by a stool test for the presence of toxigenic C. difficile or C. difficile toxin
• be eligible for FMT as judged by the investigator or current treatment guidelines for rCDI in the US
• be a candidate for colonoscopy as judged by the investigator

You may not qualify if…

• Use or planned use of systemic antibiotics for an indication other than the qualifying rCDI episode.
• Current uncontrolled chronic diarrhea not related to CDI.
• Receipt of CDI vaccine or treatment with CDI monoclonal antibodies within the past 12 months before screening.
• Evidence of active, severe, or fulminant colitis, diagnosis of toxic megacolon or have a current colostomy or ileostomy

Where it is running

• Ferring Investigational Site — North Little Rock, Arkansas, United States
• Ferring Investigational Site — Camarillo, California, United States
• Ferring Investigational Site — Hamden, Connecticut, United States
• Ferring Investigational Site — Idaho Falls, Idaho, United States
• Ferring Investigational Site — Gurnee, Illinois, United States
• Ferring Investigational Site — Shreveport, Louisiana, United States
• Ferring Investigational Site — Plymouth, Minnesota, United States
• Ferring Investigational Site — Rochester, Minnesota, United States
• Ferring Investigational Site — Cleveland, Ohio, United States
• Ferring Investigational Site — Oklahoma City, Oklahoma, United States
• Ferring Investigational Site — Burke, Virginia, United States
• Ferring Investigational Site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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