General Information

Rebyota (fecal microbiota, live - jslm) is a microbiota-based live biotherapeutic product.

Rebyota is specifically indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI.

Rebyota is supplied as a suspension for rectal administration. Administer Rebyota 24 to 72 hours after the last dose of antibiotics for CDI as a single 150 mL rectal dose.

Mechanism of Action

Rebyota  (fecal microbiota, live – jslm) is an opaque fecal microbiota suspension for rectal administration. Rebyota is manufactured from human fecal matter sourced from qualified donors. The human fecal matter is tested for a panel of transmissible pathogens. Rebyota can control CDI by adding healthy bacteria into the recipient’s intestines.

Side Effects

Adverse effects associated with the use of Rebyota may include, but are not limited to, the following:

• abdominal pain
• diarrhea
• abdominal distention
• flatulence
• nausea

Clinical Trial Results

The FDA approval of Rebyota was based on the phase 3 PUNCH CD3  trial in which a single dose of Rebyota demonstrated superiority to placebo as a treatment to reduce recurrence of CDI after standard-of-care antibiotic treatment. The randomized, double-blind, placebo-controlled trial enrolled 262 subjects. The primary endpoint was treatment success, defined as the absence of CDI diarrhea within eight weeks after completing study treatment. The Bayesian model-estimated treatment success rate at eight weeks for Rebyota was 70.6% versus 57.5% for placebo, with a 99.1% posterior probability that Rebyota was superior to placebo in reducing recurrent CDI after standard-of-care antibiotic treatment. More than 90% of study participants who achieved treatment success remained free of CDI recurrence through six months.