Phase 3
Completed N=41
A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection
Clostridium Difficile Infection Recurrence
Source: ClinicalTrials.gov NCT05831189 ↗
Enrolled (actual)
41
Serious AEs
4.9%
Results posted
Apr 2026
Primary outcomePrimary: Number of Participants With RBX2660-related Treatment-emergent Adverse Events (TEAEs) After RBX2660 Treatment Delivered by Colonoscopy Through 8 Weeks, or Treatment Failure — 18 Participants
◆ Published Evidence
Emerging
6citations · ~6 / year
Safety and effectiveness of fecal microbiota, live-jslm (REBYOTA<sup>®</sup>) administered by colonoscopy for prevention of recurrent <i>Clostridioides difficile</i> infection: 8-week results from CDI-SCOPE, a single-arm, phase IIIb trial.
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.
Linked Publications (3)
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Safety and effectiveness of fecal microbiota, live-jslm (REBYOTA<sup>®</sup>) administered by colonoscopy for prevention of recurrent <i>Clostridioides difficile</i> infection: 8-week results from CDI-SCOPE, a single-arm, phase IIIb trial.
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Prevention of recurrent <i>Clostridioides difficile</i> infection by fecal microbiota, live-jslm (REBYOTA<sup>®</sup>) administered via colonoscopy: 6-month data from the single-arm phase IIIb CDI-SCOPE trial.
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Patient-reported benefits of colonoscopicallyadministered microbiota restoration therapy: a qualitative study of adult patients with recurrent <i>Clostridioides difficile</i> infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With RBX2660-related Treatment-emergent Adverse Events (TEAEs) After RBX2660 Treatment Delivered by Colonoscopy Through 8 Weeks, or Treatment Failure |
18 | — |
| SECONDARY Number of Participants With Recurrence of Clostridioides Difficile Infection (CDI) Within 8 Weeks After RBX2660 Treatment Delivered by Colonoscopy. |
2 | — |
| SECONDARY Time to CDI Recurrence From Baseline Through 8 Weeks After RBX2660 Treatment Delivered by Colonoscopy |
— | — |
| SECONDARY Physician-experience, as Determined by Questionnaire, Documenting Subjective Experience of Investigators on Usability of RBX2660 in Clinical Practice When Delivered by Colonoscopy |
2; 20; 19; 0; 0; 0 | — |
| SECONDARY 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 |
26; 13 | — |
| SECONDARY Patient-experience Interview at 8 Weeks, or at Treatment Failure, After RBX2660 Treatment Delivered by Colonoscopy |
26; 13 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events up to 8 Weeks or Treatment Failure After RBX2660 Treatment |
18; 14; 3; 2; 1; 0 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) |
2 | — |
| SECONDARY Number of Participants With Any Adverse Events of Special Interest (AESIs) |
2 | — |
| SECONDARY Number of Participants With Adverse Events Leading to Death or Intensive Care Unit (ICU) Admission |
2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05831189) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.