Fecal microbiota is a bacterial suspension manufactured from human fecal matter used to prevent the recurrence of Clostridioides difficile infection. Although the incidence of CDI has declined and the number of cases requiring hospitalization has been lower over the years, the recurrence of CDI still represents a challenge.
- Mechanism
- Curator reviewed · 3 references
The mechanism of action of fecal microbiota has not been established. In the prevention of the recurrence of Clostridioides difficile infection (CDI), it is possible that the reintroduction of normal flora from donors corrects the intestinal imbalance of microorganisms. Antibiotics, such as clindamycin, are used in the treatment of CDI; however, they can also lead to a chronic and contagious condition characterized by low phylotypic diversity, the presence of opportunistic pathogens, the upregulation of pro-inflammatory genes and the reduction of colon nutrients. The use of fecal microbiota transplantations increases the diversity of fecal microbiota as well as the proportion of "beneficial" bacteria.
- Primary indication
- Fecal microbiota is 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.Curator reviewed · 2 structured indications
- First approval
- Canada, 2025 · United States, 2023
- Also known as
- Donor human stool · Donor human stool spores (ethanol treated) · Fecal Microbial Transplantation · Fecal Microbiota for Transplant · Fecal microbiota spores, live-brpk
- Code names
- CP-101
- Brand names
Resolves to
What you can answer from here — as of December 12, 2025
Which other approved drugs treat the same conditions as Fecal microbiota, and which companies have late-stage candidates in those indications?
Create a free account or log in to explore the full data card.
Create Account