REBYOTA™ for Clostridium Difficile
(ROAR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to gather information on the use of REBYOTA™ (a microbiota-based treatment) to prevent recurrent Clostridioides difficile infection (rCDI), a gut infection that often returns after treatment. The study observes patients already prescribed REBYOTA™ by their doctors and collects data from medical records for six months following treatment. Suitable candidates for this trial have been diagnosed with rCDI, completed their antibiotic treatment, and are prescribed REBYOTA™ to prevent the infection's recurrence.
As a Phase 4 trial, this study focuses on understanding how this FDA-approved and effective treatment benefits a broader patient population.
Do I need to stop my current medications to join the trial?
The trial does not specify whether you need to stop taking your current medications. Since it's an observational study, it's likely you can continue your current treatments, but you should confirm with your doctor.
What is the safety track record for REBYOTA™?
Research has shown that REBYOTA™ is generally well-tolerated. Five clinical trials found it safe for adults with recurring C. diff infections. These studies consistently demonstrated the treatment's safety. Side effects were minor and similar to those seen with a placebo, a harmless pill used for comparison.
Additionally, the FDA has approved REBYOTA™ to help prevent C. diff infections from returning after antibiotic treatment, indicating it has met strict safety standards. Overall, the evidence suggests that REBYOTA™ is a safe choice for people with recurring C. diff infections.12345Why are researchers excited about this trial?
Unlike the standard treatments for recurrent Clostridioides difficile infection, which often involve antibiotics, REBYOTA™ offers a novel approach by using a fecal microbiota transplantation (FMT). This treatment introduces a diverse array of healthy bacteria directly into the gut, aiming to restore the natural balance of the microbiome. Researchers are excited about REBYOTA™ because it targets the root cause of the infection by replenishing the gut flora, potentially reducing recurrence rates and offering a more lasting solution compared to conventional antibiotic therapies.
What evidence suggests that REBYOTA™ is effective for preventing rCDI?
Research has shown that REBYOTA™, the treatment under study in this trial, effectively prevents repeat Clostridioides difficile infections (rCDI). One study reported an 87.7% success rate, with most patients remaining infection-free eight weeks after treatment. Another study demonstrated a 95% success rate over the same period. For individuals with weakened immune systems, the success rate was 75.7% at eight weeks and 88.7% at six months. These findings suggest that REBYOTA™ can be a strong option for preventing rCDI.46789
Who Is on the Research Team?
Global Clinical Compliance
Principal Investigator
Ferring Pharmaceuticals
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive REBYOTA™ for the prevention of recurrent Clostridioides Difficile Infection (rCDI)
Follow-up
Data about clinical history, CDI events, symptoms, treatments, medical procedures, Adverse Events, and healthcare resource utilization are collected through 6 months of follow-up
What Are the Treatments Tested in This Trial?
Interventions
- REBYOTA™
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ferring Pharmaceuticals
Lead Sponsor
Pierre-Yves Berclaz
Ferring Pharmaceuticals
Chief Medical Officer since 2023
MD from the University of Lausanne, PhD in Molecular Biology from the Cincinnati College of Medicine
Jean-Frédéric Paulsen
Ferring Pharmaceuticals
Chief Executive Officer since 2023
Master’s degree in Finance from the London School of Economics and Political Science
Citations
Ferring Presents New Real-World REBYOTA® (fecal ...
Importantly, treatment success was 87.8% (36/41) in the subgroup that received REBYOTA after an antibiotic washout period >72 hours, with ...
2.
ferringusa.com
ferringusa.com/?press=ferring-presents-real-world-outcomes-data-analyses-for-rebyota-fecal-microbiota-live-jslm-at-idweek-2024jslm) at IDWeek 2024
The overall treatment success rate (no CDI recurrence at Week 8) was 87.7% (87.3% [62/71] in RBL-naïve; 100% [2/2] in previously RBL-treated).
Safety and Efficacy of Fecal Microbiota, Live-jslm ...
Efficacy outcomes included treatment success at 8 weeks and sustained clinical response at 6 months. Results: Overall, 793 participants were ...
4.
cidrap.umn.edu
cidrap.umn.edu/antimicrobial-stewardship/trial-data-show-rebyota-safe-effective-immune-compromised-patientsTrial data show Rebyota is safe, effective in immune- ...
In immunocompromised participants, the treatment success rate at 8 weeks was 75.7% and the sustained clinical response rate at 6 months was 88.7 ...
Ferring Presents New Data Analyses for REBYOTA® (fecal ...
Overall, 41 participants received REBYOTA, 39 of whom completed an 8-week visit, with a treatment success rate of 95%. For the ACG presentation, ...
6.
ferringusa.com
ferringusa.com/?press=ferring-presents-new-data-analyses-for-rebyota-fecal-microbiota-live-jslm-at-acg-2025Ferring Presents New Data Analyses for REBYOTA® (fecal ...
The CDI-SCOPE trial is a multicenter, single-arm, phase 3b study evaluating the safety and efficacy of REBYOTA when administered by colonoscopy ...
Safety of fecal microbiota, live-jslm (REBYOTA™) in ...
Across five clinical trials, RBL was well tolerated in adults with rCDI. In aggregate, these data consistently demonstrated the safety of RBL.
Package Insert - REBYOTA
The safety of REBYOTA was evaluated in 2 randomized, double-blind clinical ... Only data from the REBYOTA one-dose group and the placebo group are.
REBYOTA® (fecal microbiota, live- jslm) | Patient Website
REBYOTA® is the 1st and only single-dose, FDA-approved microbiome-based therapy to keep recurrent C. diff infection from coming back, after antibiotics.
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