NCT05831189

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Clostridium Difficile Infection Recurrence

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2023-04-21
• Primary completion: 2025-01-17
• Completion: 2025-01-17
• First posted: 2023-04-26
• Last updated: 2025-12-17

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study