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Clostridium Difficile Infection RecurrencePhase 3CDI-SCOPENCT05831189

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

A Phase 3 study testing RBX2660 in people with Clostridium Difficile Infection Recurrence, run by Ferring Pharmaceuticals at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
RBX2660
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
12 sitesUnited States
Study dates
21 Apr 2023to 17 Jan 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Ferring Investigational Site

    Burke, Virginia, 22015

  • Ferring Investigational Site

    Camarillo, California, 93012

  • Ferring Investigational Site

    Cleveland, Ohio, 44195

  • Ferring Investigational Site

    Gurnee, Illinois, 60031

  • Ferring Investigational Site

    Hamden, Connecticut, 06518

  • Ferring Investigational Site

    Idaho Falls, Idaho, 83404

  • Ferring Investigational Site

    Madison, Wisconsin, 53705

  • Ferring Investigational Site

    North Little Rock, Arkansas, 72117

  • Ferring Investigational Site

    Oklahoma City, Oklahoma, 73102

  • Ferring Investigational Site

    Plymouth, Minnesota, 55446

  • Ferring Investigational Site

    Rochester, Minnesota, 55905

  • Ferring Investigational Site

    Shreveport, Louisiana, 71105

Other trials in United States

About this study

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.

Being tested
RBX2660
Keywords
C. Difficile Diarrhea, Clostridium Difficile, CDI, FMT, Fecal Microbiota Transplant, Microbiota Restoration Therapy, Diarrhea, Microbial Suspension, Fecal Transplant, C Difficile Colitis, Clostridium Difficile Associated Diarrhea, C diff diarrhea, C Difficile, C diff
Medical subject headings
Diarrhea, Enterocolitis, Pseudomembranous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RBX2660Drug

    Also called REBYOTA®

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

Study groups in NCT05831189
Study groupRoleWhat they receive
RBX2660ExperimentalNot described
Receives: Drug: RBX2660

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 8 weeks after RBX2660 treatment delivered by colonoscopy

Secondary outcomes (9)

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Up to 8 weeks after RBX2660 treatment delivered by colonoscopy

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

    Measured: Up to 8 weeks after RBX2660 treatment delivered by colonoscopy

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

    Measured: 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

    Measured: Up to 8 weeks after RBX2660 treatment delivered by colonoscopy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2023
  2. Study start21 Apr 2023
  3. Primary completion17 Jan 2025
  4. Study completion17 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05831189
Sponsor's protocol ID
000416
Acronym
CDI-SCOPE
Status last verified
Mar 2026
First submitted
14 Apr 2023
Last updated
24 Apr 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Khanna S, Yoho D, Van Handel D, Clark BJ, Awad T, Guthmueller B, Armandi D, Knapple W, Safdar N, Baggott B, Simon K, Feuerstadt P. Safety and effectiveness of fecal microbiota, live-jslm (REBYOTA(R)) administered by colonoscopy for prevention of recurrent Clostridioides difficile infection: 8-week results from CDI-SCOPE, a single-arm, phase IIIb trial. Ther Adv Gastroenterol. 2025 Apr 22;18:17562848251339697. doi: 10.1177/17562848251339697. eCollection 2025.

    PubMed 40321366

  • Khanna S, Yoho D, Van Handel D, Clark BJ, Awad T, Guthmueller B, Armandi D, Knapple W, Safdar N, Baggott B, Simon K, Feuerstadt P. Prevention of recurrent Clostridioides difficile infection by fecal microbiota, live-jslm (REBYOTA(R)) administered via colonoscopy: 6-month data from the single-arm phase IIIb CDI-SCOPE trial. Ther Adv Gastroenterol. 2025 Nov 9;18:17562848251396744. doi: 10.1177/17562848251396744. eCollection 2025.

    PubMed 41230019

  • McCool-Myers M, Umanzor-Figueroa C, Symonds T, Landeira M, Awad T, Armandi D, Guthmueller B, Khanna S. Patient-reported benefits of colonoscopicallyadministered microbiota restoration therapy: a qualitative study of adult patients with recurrent Clostridioides difficile infection. Ther Adv Gastroenterol. 2025 Nov 14;18:17562848251392102. doi: 10.1177/17562848251392102. eCollection 2025.

    PubMed 41647268

  • Chopra T, Van Handel D, Baggott B, Orenstein R, Reveles K, Guthmueller B, Srivastava S, Khanna S. Efficacy Outcomes of Fecal Microbiota, Live-jslm in Preventing Recurrent Clostridioides difficile Infection from Seven Clinical Studies. Infect Dis Ther. 2026 Aug;15(8):2071-2086. doi: 10.1007/s40121-026-01374-9. Epub 2026 Jun 12.

    PubMed 42286373

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RBX2660 in people with Clostridium Difficile Infection Recurrence, run by Ferring Pharmaceuticals at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05831189, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.

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