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COMPLETED
NCT05831189
PHASE3

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

View on ClinicalTrials.gov

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

DRUG

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