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Fecal transplantation
Fecal microbiota transplantation restores a healthy gut microbiome by transferring bacterial communities from a healthy donor to a patient with dysbiosis.
Fecal microbiota transplantation restores a healthy gut microbiome by transferring bacterial communities from a healthy donor to a patient with dysbiosis. Used for Clostridioides difficile infection (recurrent or refractory), Inflammatory bowel disease (Crohn's disease, ulcerative colitis).
At a glance
| Generic name | Fecal transplantation |
|---|---|
| Also known as | Fecal microbial transplantation |
| Sponsor | Bogomolets National Medical University |
| Drug class | Microbiota therapeutic |
| Modality | Biologic |
| Therapeutic area | Gastroenterology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
FMT introduces diverse microbial populations into the patient's gastrointestinal tract, reestablishing beneficial bacteria and restoring microbial diversity. This reconstitution of the microbiota helps restore normal intestinal barrier function, immune homeostasis, and metabolic processes that are disrupted in dysbiotic states. The restored microbiota competes with pathogenic organisms and produces short-chain fatty acids and other metabolites essential for gut health.
Approved indications
- Clostridioides difficile infection (recurrent or refractory)
- Inflammatory bowel disease (Crohn's disease, ulcerative colitis)
Common side effects
- Abdominal pain or cramping
- Diarrhea
- Nausea
- Fever
- Flatulence or bloating
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
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |