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Fecal Microbiota
Fecal microbiota transplantation (FMT) restores a healthy gut bacterial community by introducing donor microorganisms to treat dysbiosis-related conditions.
Fecal microbiota transplantation (FMT) restores a healthy gut bacterial community by introducing donor microorganisms to treat dysbiosis-related conditions. Used for Clostridioides difficile infection (recurrent or refractory), Ulcerative colitis, Crohn's disease.
At a glance
| Generic name | Fecal Microbiota |
|---|---|
| Also known as | stool transplant, fecal microbial transplantation, FMT, Washed fecal microbiota, FMT Therapy |
| Sponsor | University of California, San Francisco |
| Drug class | Biotherapeutic; microbiota restoration therapy |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology; Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
FMT works by transferring stool from a healthy donor into the gastrointestinal tract of a patient with dysbiosis, reestablishing beneficial bacterial populations and their metabolic functions. This restores microbial diversity and competitive exclusion of pathogenic organisms, particularly Clostridioides difficile. The restored microbiota produces short-chain fatty acids and other metabolites that support intestinal barrier function and immune homeostasis.
Approved indications
- Clostridioides difficile infection (recurrent or refractory)
- Ulcerative colitis
- Crohn's disease
Common side effects
- Abdominal pain or cramping
- Diarrhea
- Nausea
- Fever
- Flatulence
Key clinical trials
- LND101 for Fecal Microbiota Transplantation in Combination With Immune Checkpoint Blockade in Advanced Melanoma (PHASE2)
- Implications of Fecal Microbiota Transplantation in Modulating the Effects of Liver Cirrhosis (PHASE3)
- Effect of Oral Microbiota on MDRO Decolonization (PHASE1, PHASE2)
- Efficacy and Mechanism of Fecal Microbiota Transplantation of the Bai Nationality in the Treatment of IBD (NA)
- Fecal Microbiota Transplant (PHASE4)
- Intestinal Microbiota Transplantation in Patients With Chronic Heart Failure (PHASE1)
- Study of Healthy Donor FMT (hdFMT) and Pembrolizumab in Relapsed/Refractory (R/R) PD-L1 Positive NSCLC (PHASE2)
- Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder. (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Fecal Microbiota CI brief — competitive landscape report
- Fecal Microbiota updates RSS · CI watch RSS
- University of California, San Francisco portfolio CI