News|Articles|October 22, 2025

Data From Two Rebyota Trials Show Quality of Life Improvements | IDWeek 2025

Author(s)Logan Lutton

Rebyota improves quality of life for patients with recurrent C. difficile (C. diff) infections, according to two analyses of real-world data presented at IDWeek 2025.

Data analyses from two real-world trials of Rebyota (fecal microbiota, live-jslm)efficacy and safety will be presented at IDWeek 2025, according to the details of a recent Ferring Pharmaceuticals news release. IDWeek 2025 is being held from Oct. 19-22 in Atlanta, Georgia.

Rebyota is the first and only FDA-approved single-dose fecal microbiota transplant (FMT) for the prevention of recurrent C. difficile (C. diff) infection in individuals 18 years of age and older, following antibiotic treatment.

The first analysis, a presentation, will highlight results that showed 75% of patients with recurrent Clostridioides difficile infection (rCDI) had no CDI recurrence at eight weeks. Patients were given Rebyota in physician offices between February 2023 and March 2025.

The second analysis, a presentation of an abstract poster, reports early results from an ongoing study of 76 patients who have received Rebyota within 30 days of completing antibiotics for rCDI and have completed eight weeks of follow-up. More than three-quarters (83%) of patients saw no rCDI recurrence through eight weeks. Additionally, 88% of patients who received Rebyota after an antibiotic washout period of more than 72 hours had no rCDI recurrence.

Adverse events were consistent across both trials and there were no new safety concerns noted. Specifically, 18 of the patients experienced an adverse event, six experienced a serious adverse event, and one experienced a fatal, large bowel obstruction, which was considered unrelated to Rebyota.

C. Diff is a potentially deadly infection of the colon that affects approximately 500,000 people in the United States annually. Of those, approximately 30,000 will die.

Symptoms include severe diarrhea, fever, stomach tenderness and inflammation of the colon, otherwise known as colitis. Antibiotics are used to treat the infection but may also be a contributor to infection reoccurrence due to antibiotic resistance. For example, up to 35% of patients have a recurrence after an initial diagnosis and up to 65% of patients may develop subsequent reoccurrence. This reoccurrence is a considerable burden to patients and the healthcare system due to inpatient care costs and lost productivity from patients missing work. It’s estimated CDI costs the healthcare system nearly $5 billion annually, of which rCDI costs $2.8 billion annually.

Rebyota was originally approved by the FDA in 2022, using data from five clinical studies, according to the prescribing information. Rebyota comes as a single-dose 150-mL microbiota suspension, which consists of a liquid mix of trillions of live microbes, including Bacteroides, which are frequently used to restore the gut biome. It is administered rectally by a healthcare professional. The most common side effects of Rebyota are stomach pain (9%), diarrhea (7%) and bloating (4%).

“Recurrent C. diff infection remains a critical public health issue marked by a vicious cycle of recurrent infections that can significantly diminish a patient’s quality of life for both them and the family around them,” Nicholas W. Van Hise, Pharm.D., Metro Infectious Disease Consultants, said in the news release. “The findings from these real-world studies are highly encouraging, as they support the vital role of a single-dose FDA-approved microbiota-based live biotherapeutic product in the prevention of rCDI. This health-related quality of life data underscores the profound impact that halting the cycle of recurrence can have on patients’ daily lives, extending beyond just clinical outcomes.”

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