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

NCT ID: NCT05831189

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-21

Study Completion Date

2025-01-17

Brief Summary

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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.

Detailed Description

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Conditions

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Clostridium Difficile Infection Recurrence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RBX2660

Group Type EXPERIMENTAL

RBX2660

Intervention Type 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).

Interventions

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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).

Intervention Type DRUG

Other Intervention Names

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REBYOTA®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Compliance

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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Ferring Investigational Site

North Little Rock, Arkansas, United States

Site Status

Ferring Investigational Site

Camarillo, California, United States

Site Status

Ferring Investigational Site

Hamden, Connecticut, United States

Site Status

Ferring Investigational Site

Idaho Falls, Idaho, United States

Site Status

Ferring Investigational Site

Gurnee, Illinois, United States

Site Status

Ferring Investigational Site

Shreveport, Louisiana, United States

Site Status

Ferring Investigational Site

Plymouth, Minnesota, United States

Site Status

Ferring Investigational Site

Rochester, Minnesota, United States

Site Status

Ferring Investigational Site

Cleveland, Ohio, United States

Site Status

Ferring Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

Ferring Investigational Site

Burke, Virginia, United States

Site Status

Ferring Investigational Site

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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. Therap Adv Gastroenterol. 2025 Apr 22;18:17562848251339697. doi: 10.1177/17562848251339697. eCollection 2025.

Reference Type RESULT
PMID: 40321366 (View on PubMed)

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. Therap Adv Gastroenterol. 2025 Nov 9;18:17562848251396744. doi: 10.1177/17562848251396744. eCollection 2025.

Reference Type RESULT
PMID: 41230019 (View on PubMed)

McCool-Myers M, Umanzor-Figueroa C, Symonds T, Landeira M, Awad T, Armandi D, Guthmueller B & Khanna S. Patient-reported benefits of colonoscopically administered microbiota restoration therapy: a qualitative study of adult patients with recurrent Clostridioides difficile infection. Therapeutic Advances in Gastroenterology. 2025 Nov 14; 18:17562848251392102. doi: 10.1177/17562848251392102.

Reference Type RESULT

Related Links

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https://pubmed.ncbi.nlm.nih.gov/40321366/

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

https://pubmed.ncbi.nlm.nih.gov/41230019/

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.

Other Identifiers

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000416

Identifier Type: -

Identifier Source: org_study_id