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Completed

NCT Number: 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

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.

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Key information

Conditions

Clostridium Difficile Infection Recurrence Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Diarrhea Digestive System Diseases Enterocolitis Enterocolitis, Pseudomembranous Gastroenteritis Gastrointestinal Diseases Gram-Positive Bacterial Infections Infections Intestinal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ferring Investigational Site, North Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

RBX2660

Drug

RBX2660 should be administered to the right side of the colon (i.e., between the ileocecal valve and the hepatic flexure of the colon).

Other names: REBYOTA®

Primary outcomes

  1. Number of Participants With RBX2660-related Treatment-emergent Adverse Events (TEAEs) After RBX2660 Treatment Delivered by Colonoscopy Through 8 Weeks, or Treatment Failure

    Time frame: 8 weeks after RBX2660 treatment delivered by colonoscopy

Secondary outcomes

  1. Number of Participants With Recurrence of Clostridioides Difficile Infection (CDI) Within 8 Weeks After RBX2660 Treatment Delivered by Colonoscopy.

    Time frame: Within 8 weeks after RBX2660 treatment delivered by colonoscopy

  2. Time to CDI Recurrence From Baseline Through 8 Weeks After RBX2660 Treatment Delivered by Colonoscopy

    Time frame: 8 weeks after RBX2660 treatment delivered by colonoscopy

  3. Physician-experience, as Determined by Questionnaire, Documenting Subjective Experience of Investigators on Usability of RBX2660 in Clinical Practice When Delivered by Colonoscopy

    Time frame: At Day 1 (baseline visit)

  4. Physician Perception of Patient Benefit, as Determined by Number of Participants With Clinician Global Impression of Improvement (CGI-I) at 8 Weeks, or at Treatment Failure, After RBX2660 Treatment Delivered by Colonoscopy

    Time frame: 8 weeks after RBX2660 treatment delivered by colonoscopy

  5. Patient-experience Interview at 8 Weeks, or at Treatment Failure, After RBX2660 Treatment Delivered by Colonoscopy

    Time frame: 8 weeks after RBX2660 treatment delivered by colonoscopy

  6. Number of Participants With Treatment-emergent Adverse Events up to 8 Weeks or Treatment Failure After RBX2660 Treatment

    Time frame: Up to 8 weeks after RBX2660 treatment delivered by colonoscopy

  7. Number of Participants With Serious Adverse Events (SAEs)

    Time frame: Up to 8 weeks after RBX2660 treatment delivered by colonoscopy

  8. Number of Participants With Any Adverse Events of Special Interest (AESIs)

    Time frame: Up to 8 weeks after RBX2660 treatment delivered by colonoscopy

  9. Number of Participants With Adverse Events Leading to Death or Intensive Care Unit (ICU) Admission

    Time frame: Up to 8 weeks after RBX2660 treatment delivered by colonoscopy

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Acronym: CDI-SCOPE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 26, 2023
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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