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A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection
Sponsor: Ferring Pharmaceuticals
Summary
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 Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
41
Start Date
2023-04-21
Completion Date
2025-01-17
Last Updated
2026-04-24
Healthy Volunteers
No
Interventions
RBX2660
RBX2660 should be administered to the right side of the colon (i.e., between the ileocecal valve and the hepatic flexure of the colon).
Locations (12)
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