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Healthy donor stool
Healthy donor stool restores the patient's gut microbiota composition and function through fecal microbiota transplantation (FMT).
Healthy donor stool restores the patient's gut microbiota composition and function through fecal microbiota transplantation (FMT). Used for Clostridioides difficile infection (recurrent or refractory), Inflammatory bowel disease (Crohn's disease or ulcerative colitis).
At a glance
| Generic name | Healthy donor stool |
|---|---|
| Also known as | Fecal microbiota transplantation, FMT |
| Sponsor | Helsinki University Central Hospital |
| Drug class | Biotherapeutic microbiota product |
| Modality | Biologic |
| Therapeutic area | Gastroenterology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
FMT introduces a diverse community of commensal bacteria from a healthy donor into the patient's gastrointestinal tract, reestablishing a balanced microbiome. This restores microbial diversity, metabolic function, and competitive exclusion of pathogenic organisms, thereby improving intestinal barrier function and immune homeostasis. The mechanism is primarily ecological rather than targeting a single molecular pathway.
Approved indications
- Clostridioides difficile infection (recurrent or refractory)
- Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
Common side effects
- Gastrointestinal symptoms (abdominal pain, bloating, diarrhea)
- Fever
- Nausea
- Infection or bacteremia (rare)
Key clinical trials
- Implications of Fecal Microbiota Transplantation in Modulating the Effects of Liver Cirrhosis (PHASE3)
- Blood Donor CVD 5000 (PHASE4)
- Effect of Oral Microbiota on MDRO Decolonization (PHASE1, PHASE2)
- Intestinal Microbiota Transplantation in Patients With Chronic Heart Failure (PHASE1)
- Collection of Data and Samples From Healthy Donors for Use in Translational Research
- 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)
- Using Healthy Gut Bacteria to Boost Immune Treatment for Advanced Bowel Cancer (EARLY_PHASE1)
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 |