Recurrence of Clostridium Difficile InfectionROARNCT05835219
REBYOTA™ Prospective Registry
An observational study of Recurrence of Clostridium Difficile Infection, run by Ferring Pharmaceuticals at 42 sites in United States.
Trial summary
This is a prospective observational cohort study designed to collect data on patients who received REBYOTA™ for the prevention of rCDI in the routine care setting. As all data collected for this study are observational, the decision to prescribe REBYOTA™ is at the treating physician's discretion and independent from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrence of Clostridium Difficile Infection
- What is being tested?
- REBYOTA™
- How many people
- 145 participants
- Where
- 42 sitesUnited States
- Study dates
- 19 Jun 2023to 29 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Subjects who have received antibiotic treatment for Clostridioides Difficile Infection
Who may be able to join
- Signed and dated informed consent form (ICF)
- Age ≥ 18 years
- Diagnosis of rCDI as determined by the treating physician
- Completed antibiotic treatment for the presenting rCDI episode
- Prescription for REBYOTA™ to prevent rCDI according to the approved indication
Who cannot join
- Currently enrolled in an interventional clinical trial
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
Ferrin Investigational Site
Atlanta, Georgia, 30322
Ferring Investigational Site
Boston, Massachusetts, 02115
Ferring Investigational Site
Burr Ridge, Illinois, 60527
Ferring Investigational Site
Chandler, Arizona, 85224
Ferring Investigational Site
Charleston, South Carolina, 29425
Ferring Investigational Site
Charlottesville, Virginia, 22903
Ferring Investigational Site
Chula Vista, California, 91910
Ferring Investigational Site
Cincinnati, Ohio, 45267
Ferring Investigational Site
Dallas, Texas, 75246
Ferring Investigational Site
Detroit, Michigan, 48201
Ferring Investigational Site
Detroit, Michigan, 48202
Ferring Investigational Site
DuBois, Pennsylvania, 15801
Ferring Investigational Site
Fargo, North Dakota, 58122
Ferring Investigational Site
Farmington Hills, Michigan, 48336
Ferring Investigational Site
Gainesville, Florida, 32610
Ferring Investigational Site
Hamden, Connecticut, 06518
Ferring Investigational Site
Houston, Texas, 77030
Ferring Investigational Site
Iowa City, Iowa, 52242
Ferring Investigational Site
Jefferson, Louisiana, 70121
Ferring Investigational Site
Knoxville, Tennessee, 37909
Ferring Investigational Site
La Grange, Georgia, 30240
Ferring Investigational Site
Maywood, Illinois, 60153
Ferring Investigational Site
Middleburg Heights, Ohio, 44130
Ferring Investigational Site
Murrieta, California, 92563
Ferring Investigational Site
New York, New York, 10016
Ferring Investigational Site
New York, New York, 10021
Ferring Investigational Site
New York, New York, 10279
Ferring Investigational Site
Oceanside, California, 92054
Ferring Investigational Site
Omaha, Nebraska, 68198
Ferring Investigational Site
Orlando, Florida, 32806
Ferring Investigational Site
Pittsburgh, Pennsylvania, 15237
Ferring Investigational Site
Port Orange, Florida, 32127
Ferring Investigational Site
Rochester, New York, 14618
Ferring Investigational Site
Sacramento, California, 95816
Ferring Investigational Site
Savannah, Georgia, 31405
Ferring Investigational Site
Stony Brook, New York, 11794
Ferring Investigational Site
Tampa, Florida, 33614
Ferring Investigational Site
Teaneck, New Jersey, 07666
Ferring Investigational Site
West Jordan, Utah, 84088
Ferring Investigational Site
Wichita, Kansas, 67211
Ferring Investigational Site
Worcester, Massachusetts, 01608
Ferring Investigational Site
Zephyrhills, Florida, 33542
About this study
Official title: REBYOTA™ for the Prevention of Recurrence of Clostridioides Difficile Infection (CDI) in Adult Patients: An Observational Study
This is a prospective observational cohort study designed to collect data on patients who received REBYOTA™ for the prevention of rCDI in the routine care setting. As all data collected for this study are observational, the decision to prescribe REBYOTA™ is at the treating physician's discretion and independent from the decision to enroll the patient in the study. Data will be collected from patients' medical records after obtaining informed consent. Data about clinical history, CDI events (primary and recurrent: severity, treatment), CDI-related symptoms, treatments, medical procedures, Adverse Events(AEs), and healthcare resource utilization (i.e., hospitalizations and re-admissions) will be collected through 6 months of follow-up from the date of REBYOTA™ administration.
- Being tested
- REBYOTA™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REBYOTA™Drug
REBYOTA™ is administered in the rectum
| Study group | Role | What they receive |
|---|---|---|
| REBYOTA™ | Not described Receives: Drug: REBYOTA™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients without Recurrence of Clostridioides Difficile Infection (rCDI) (as determined by the treating physician)
Measured: 8 weeks after initial REBYOTA™ treatment
Secondary outcomes (5)
Proportion of patients with sustained clinical response, defined as treatment success of the presenting rCDI episode and no new CDI episodes occurring for more than 8 weeks through 6 months after initial REBYOTA™ treatment
Measured: 6 months after initial REBYOTA™ treatment
Total number of CDI episodes
Measured: 6 months after initial REBYOTA™ treatment
Time to any CDI episode
Measured: 6 months after initial REBYOTA™ treatment
Daily mean changes in Clostridium difficile Infection-Daily Symptoms (CDIDaySyms™) scores from baseline to 7 days after REBYOTA™ administration
Measured: 7 days after REBYOTA™ administration
Hospitalizations and re-admissions during follow-up for up to 6 months (all-cause and CDI-related) after receiving REBYOTA™
Measured: Up to 6 months after receiving REBYOTA™
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start19 Jun 2023
- Primary completion29 Aug 2025
- Study completion29 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrence of Clostridium Difficile InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835219
- Sponsor's protocol ID
- 000422
- Acronym
- ROAR
- Status last verified
- Jan 2026
- First submitted
- 18 Apr 2023
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REBYOTA™ for the Prevention of Recurrence of Clostridioides Difficile Infection (CDI) in Adult Patients: An Observational Study
- ClinicalTrials.gov ID
- NCT05835219
- Acronym / sponsor ID
- ROAR / 000422
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 29 Aug 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective observational cohort study designed to collect data on patients who received REBYOTA™ for the prevention of rCDI in the routine care setting. As all data collected for this study are observational, the decision to prescribe REBYOTA™ is at the treating physician's discretion and independent from the decision to enroll the patient in the study. Data will be collected from patients' medical records after obtaining informed consent. Data about clinical history, CDI events (primary and recurrent: severity, treatment), CDI-related symptoms, treatments, medical procedures, Adverse Events(AEs), and healthcare resource utilization (i.e., hospitalizations and re-admissions) will be collected through 6 months of follow-up from the date of REBYOTA™ administration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| REBYOTA™ | – | Drug: REBYOTA™ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have received antibiotic treatment for Clostridioides Difficile Infection
Key inclusion criteria (5 listed)
- Signed and dated informed consent form (ICF)
- Age ≥ 18 years
- Diagnosis of rCDI as determined by the treating physician
- Completed antibiotic treatment for the presenting rCDI episode
- Prescription for REBYOTA™ to prevent rCDI according to the approved indication
Key exclusion criteria (1 listed)
- Currently enrolled in an interventional clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REBYOTA™REBYOTA™ is administered in the rectum | Drug | REBYOTA™ |
Primary outcome
Proportion of patients without Recurrence of Clostridioides Difficile Infection (rCDI) (as determined by the treating physician)
Time frame: 8 weeks after initial REBYOTA™ treatment
5 secondary outcomes
Proportion of patients with sustained clinical response, defined as treatment success of the presenting rCDI episode and no new CDI episodes occurring for more than 8 weeks through 6 months after initial REBYOTA™ treatment
Time frame: 6 months after initial REBYOTA™ treatment
Total number of CDI episodes
Time frame: 6 months after initial REBYOTA™ treatment
Time to any CDI episode
Time frame: 6 months after initial REBYOTA™ treatment
Daily mean changes in Clostridium difficile Infection-Daily Symptoms (CDIDaySyms™) scores from baseline to 7 days after REBYOTA™ administration
Time frame: 7 days after REBYOTA™ administration
Hospitalizations and re-admissions during follow-up for up to 6 months (all-cause and CDI-related) after receiving REBYOTA™
Time frame: Up to 6 months after receiving REBYOTA™
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Recurrence of Clostridium Difficile Infection
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RecruitingPhase 2
ACX-362E [Ibezapolstat] for Oral Treatment of Recurrent Clostridioides Difficile Infection
Clostridium Difficile Infection Recurrence
RecruitingPhase 2
Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody
Clostridioides Difficile Infection
Active, not recruitingPhase 2/3
LMN-201 for Prevention of C. Difficile Infection Recurrence
Clostridioides Difficile Infection
RecruitingPhase 3
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Compliance study director
Ferring Pharmaceuticals
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrence of Clostridium Difficile Infection, run by Ferring Pharmaceuticals at 42 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 5 inclusion and 1 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 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients without Recurrence of Clostridioides Difficile Infection (rCDI) (as determined by the treating physician) (time frame: 8 weeks after initial REBYOTA™ treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2026.