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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RBX2660 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With RBX2660-related Treatment-emergent Adverse Events (TEAEs) After RBX2660 Treatment Delivered by Colonoscopy Through 8 Weeks, or Treatment Failure | 8 weeks after RBX2660 treatment delivered by colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Recurrence of Clostridioides Difficile Infection (CDI) Within 8 Weeks After RBX2660 Treatment Delivered by Colonoscopy. | Within 8 weeks after RBX2660 treatment delivered by colonoscopy | |
| Time to CDI Recurrence From Baseline Through 8 Weeks After RBX2660 Treatment Delivered by Colonoscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Compliance | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ferring Investigational Site | North Little Rock | Arkansas | 72117 | United States | ||
| Ferring Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40321366 | Result | 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. | |
| 41230019 |
| Label | URL |
|---|---|
| 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 | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | RBX2660 | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 10, 2023 |
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| 8 weeks after RBX2660 treatment delivered by colonoscopy |
| Physician-experience, as Determined by Questionnaire, Documenting Subjective Experience of Investigators on Usability of RBX2660 in Clinical Practice When Delivered by Colonoscopy | At Day 1 (baseline visit) |
| 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 | 8 weeks after RBX2660 treatment delivered by colonoscopy |
| Patient-experience Interview at 8 Weeks, or at Treatment Failure, After RBX2660 Treatment Delivered by Colonoscopy | 8 weeks after RBX2660 treatment delivered by colonoscopy |
| Number of Participants With Treatment-emergent Adverse Events up to 8 Weeks or Treatment Failure After RBX2660 Treatment | Up to 8 weeks after RBX2660 treatment delivered by colonoscopy |
| Number of Participants With Serious Adverse Events (SAEs) | Up to 8 weeks after RBX2660 treatment delivered by colonoscopy |
| Number of Participants With Any Adverse Events of Special Interest (AESIs) | Up to 8 weeks after RBX2660 treatment delivered by colonoscopy |
| Number of Participants With Adverse Events Leading to Death or Intensive Care Unit (ICU) Admission | Up to 8 weeks after RBX2660 treatment delivered by colonoscopy |
| Camarillo |
| California |
| 93012 |
| United States |
| Ferring Investigational Site | Hamden | Connecticut | 06518 | United States |
| Ferring Investigational Site | Idaho Falls | Idaho | 83404 | United States |
| Ferring Investigational Site | Gurnee | Illinois | 60031 | United States |
| Ferring Investigational Site | Shreveport | Louisiana | 71105 | United States |
| Ferring Investigational Site | Plymouth | Minnesota | 55446 | United States |
| Ferring Investigational Site | Rochester | Minnesota | 55905 | United States |
| Ferring Investigational Site | Cleveland | Ohio | 44195 | United States |
| Ferring Investigational Site | Oklahoma City | Oklahoma | 73102 | United States |
| Ferring Investigational Site | Burke | Virginia | 22015 | United States |
| Ferring Investigational Site | Madison | Wisconsin | 53705 | United States |
| Result |
| 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. |
| 41647268 | Result | 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. |
| 42286373 | Derived | 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 Jun 12. doi: 10.1007/s40121-026-01374-9. Online ahead of print. |
| 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. | View source |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RBX2660 | RBX2660: RBX2660 was administered to the right side of the colon (i.e., between the ileocecal valve and the hepatic flexure of the colon). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Number of Previous CDI Episodes | Mean | Standard Deviation | Episodes |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With RBX2660-related Treatment-emergent Adverse Events (TEAEs) After RBX2660 Treatment Delivered by Colonoscopy Through 8 Weeks, or Treatment Failure | Posted | Count of Participants | Participants | 8 weeks after RBX2660 treatment delivered by colonoscopy |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Recurrence of Clostridioides Difficile Infection (CDI) Within 8 Weeks After RBX2660 Treatment Delivered by Colonoscopy. | Posted | Count of Participants | Participants | Within 8 weeks after RBX2660 treatment delivered by colonoscopy |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to CDI Recurrence From Baseline Through 8 Weeks After RBX2660 Treatment Delivered by Colonoscopy | Posted | Number | Weeks | 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 | Posted | Count of Participants | Participants | At Day 1 (baseline visit) |
|
| |||||||||||||||||||||||||||||
| 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 | Posted | Count of Participants | Participants | 8 weeks after RBX2660 treatment delivered by colonoscopy |
|
| |||||||||||||||||||||||||||||
| Secondary | Patient-experience Interview at 8 Weeks, or at Treatment Failure, After RBX2660 Treatment Delivered by Colonoscopy | Posted | Count of Participants | Participants | 8 weeks after RBX2660 treatment delivered by colonoscopy |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events up to 8 Weeks or Treatment Failure After RBX2660 Treatment | Posted | Count of Participants | Participants | Up to 8 weeks after RBX2660 treatment delivered by colonoscopy |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Adverse Events (SAEs) | Posted | Count of Participants | Participants | Up to 8 weeks after RBX2660 treatment delivered by colonoscopy |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Adverse Events of Special Interest (AESIs) | Posted | Count of Participants | Participants | Up to 8 weeks after RBX2660 treatment delivered by colonoscopy |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events Leading to Death or Intensive Care Unit (ICU) Admission | Posted | Count of Participants | Participants | Up to 8 weeks after RBX2660 treatment delivered by colonoscopy |
|
|
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RBX2660 | RBX2660: RBX2660 was administered to the right side of the colon (i.e., between the ileocecal valve and the hepatic flexure of the colon). | 0 | 41 | 2 | 41 | 6 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis Ulcerative | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Brain Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Distension | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Compliance | Ferring Pharmaceuticals A/S | 1-888-3377464 | disclosure@ferring.com |
| Mar 9, 2026 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| D004761 | Enterocolitis, Pseudomembranous |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
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| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Preparations before administration |
| |||||||||||||
| Ease of administration |
| |||||||||||||
| Activities following administration |
| |||||||||||||
| Overall experience using RBX2660 |
|
| Title | Denominators | Categories |
|---|
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| Categories |
|---|
|
| Denominators |
|---|
| Categories |
|---|
| Adverse events |
| |||||
| Mild adverse events |
| |||||
| Moderate adverse events |
| |||||
| Severe adverse events |
| |||||
| Potentially Life-threatening |
| |||||
| Adverse events leading to discontinuation |
| |||||
| Serious adverse events |
| |||||
| Adverse events leading to death |
|
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|
| Categories |
|---|
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| Somewhat negative experience |
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| Neutral experience |
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| Somewhat negative experience |
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| Neutral experience |
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| Somewhat negative experience |
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| Neutral experience |
|