From the Guidelines
Rebyota (Fecal Microbiota Transplantation) is recommended as an effective treatment for recurrent Clostridioides difficile (C. diff) infections in adults, with a high efficacy rate of around 70-80% after a single dose, as supported by the most recent guidelines from the American Gastroenterological Association (AGA) in 2024 1. The standard dosage is 150 mL of Rebyota given rectally as a one-time treatment, containing live microorganisms from human stool donations to restore the balance of gut bacteria disrupted by C. diff infections.
Key Considerations
- Before administration, patients should complete a full course of antibiotics for their current C. diff infection, with common antibiotics including vancomycin or fidaxomicin for 10-14 days 1.
- The treatment works by introducing diverse, healthy gut bacteria to outcompete and inhibit C. diff growth, helping restore normal bowel function and prevent recurrence of infection.
- Side effects are generally mild and may include abdominal pain, diarrhea, or nausea, with serious adverse events being rare but potentially including infections if the product is contaminated 1.
- Patients should be advised to stay hydrated and report any severe or persistent symptoms after treatment, with follow-up stool testing not routinely recommended unless symptoms recur.
Administration and Efficacy
- Rebyota can be administered via enema, with the AGA suggesting its use upon completion of standard of care antibiotics for recurrent C. diff infection in immunocompetent adults 1.
- The efficacy of Rebyota has been demonstrated in various studies, including a systematic review of 536 patients showing an 87% clinical response rate to fecal microbiota transplantation for recurrent C. diff infection 2.
- Another review of 317 patients treated with fecal microbiota transplantation reported a 92% clinical resolution rate, with 89% achieving resolution after a single treatment 2.
Special Considerations
- In mildly or moderately immunocompromised adults with recurrent C. diff infection, the AGA suggests the use of conventional fecal microbiota transplant upon completion of standard of care antibiotics, while suggesting against its use in severely immunocompromised adults due to very low certainty of evidence 1.
- Careful consideration is recommended before proceeding with fecal microbiota-based therapies in patients who require frequent antibiotics or long-term antibiotic prophylaxis, as ongoing antibiotics may diminish the efficacy of such therapy 1.
From the Research
Efficacy of Rebyota (Fecal Microbiota Transplantation)
- The treatment success rate of Rebyota at 8 weeks was 73.8%, with a sustained clinical response rate of 91.0% at 6 months 3.
- High efficacy rates compared to placebo with sustained response up to 24 months after administration have been reported 4.
- Patients who received Rebyota were significantly less likely to have recurrent Clostridium difficile than controls eight weeks after treatment 5.
- Rebyota has been shown to be safe and effective in reducing recurrent Clostridioides difficile infection (rCDI) in adults after antibiotic treatment 3, 4, 5, 6, 7.
Safety of Rebyota
- Treatment-emergent adverse events (TEAEs) were reported by 47.3% of participants, with most events being mild or moderate gastrointestinal disorders 3.
- Serious TEAEs were reported by 3.9% of participants 3.
- Most Rebyota-treated participants experienced TEAEs that were mild or moderate in severity and related to preexisting conditions 7.
Subgroup Analysis
- Treatment effect sizes were similar between CDI tests, higher for oral vancomycin courses >14 days versus ≤14 days and higher for antibiotic washout periods of 3 days versus ≤2 days 7.
- The largest reductions in the rate of rCDI with Rebyota versus placebo were observed for participants with a 3-day CDI antibiotic washout period and participants with ≥4 previous CDI episodes 7.