Last reviewed · How we verify
Fecal Microbiota Transplantation
Fecal microbiota transplantation (FMT) restores a healthy gut bacterial community by transferring stool from a healthy donor to a patient's colon.
Fecal microbiota transplantation (FMT) restores a healthy gut bacterial community by transferring stool from a healthy donor to a patient's colon. Used for Recurrent or refractory Clostridioides difficile infection, Ulcerative colitis (investigational), Irritable bowel syndrome (investigational).
At a glance
| Generic name | Fecal Microbiota Transplantation |
|---|---|
| Also known as | FMT, Fecal Transplant, Microbiota transfer therapy (MTT), (PRIM-DJ2727), Fecal Microbiota Preparation Delivery Capsule |
| Sponsor | University of California, Los Angeles |
| Drug class | Biologic microbiota therapeutic |
| Modality | Biologic |
| Therapeutic area | Gastroenterology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
FMT works by reintroducing diverse commensal bacteria and other microorganisms that establish a balanced microbiome, which can restore normal intestinal barrier function, competitive exclusion of pathogenic organisms, and immune homeostasis. This approach is particularly effective for recurrent or refractory Clostridioides difficile infection, where pathogenic overgrowth has disrupted the normal microbiota. The transplanted microbial community produces short-chain fatty acids, maintains pH balance, and reinforces intestinal epithelial integrity.
Approved indications
- Recurrent or refractory Clostridioides difficile infection
- Ulcerative colitis (investigational)
- Irritable bowel syndrome (investigational)
Common side effects
- Abdominal pain or cramping
- Diarrhea
- Nausea
- Fever
- Constipation
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: