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E. coli Nissle suspension
E. coli Nissle is a live biotherapeutic probiotic strain that colonizes the gut and modulates the intestinal microbiota and immune system to promote gastrointestinal health.
E. coli Nissle is a live biotherapeutic probiotic strain that colonizes the gut and modulates the intestinal microbiota and immune system to promote gastrointestinal health. Used for Maintenance of remission in ulcerative colitis, Traveler's diarrhea prevention, General gastrointestinal health and microbiota support.
At a glance
| Generic name | E. coli Nissle suspension |
|---|---|
| Also known as | Mutaflor Suspension®, Mutaflor |
| Sponsor | University of Hohenheim |
| Drug class | Live biotherapeutic product (probiotic) |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | FDA-approved |
Mechanism of action
E. coli Nissle 1917 is a non-pathogenic, commensal strain of E. coli that produces antimicrobial compounds, competes with pathogenic bacteria for nutrients and adhesion sites, and stimulates intestinal barrier function and local immune responses. It has been used clinically to maintain remission in ulcerative colitis and to support overall gut health by restoring beneficial microbiota composition.
Approved indications
- Maintenance of remission in ulcerative colitis
- Traveler's diarrhea prevention
- General gastrointestinal health and microbiota support
Common side effects
- Mild gastrointestinal symptoms (bloating, gas)
- Abdominal discomfort
Key clinical trials
- Safety, Tolerability, and Pharmacodynamics of SYNB8802v1 in Subjects With History of Gastric Bypass Surgery or Short-bowel Syndrome (EARLY_PHASE1)
- Preventing Urinary Tract Infections With E. Coli Nissle: (PHASE4)
- E. Coli Nissle 1917 - Suspension for Infection Prophylaxis (PHASE3)
- Effects of Nutritional Fat on the Growth of Intestinal E. Coli (NA)
- E. Coli Nissle in Oncology (PHASE3)
- Investigation of the Effect of E.-Coli-Nissle as Supporting Therapy to Standard Care of Diabetes Mellitus Type II (PHASE3)
- Prophylaxis of Gastrointestinal Infections With EcN (PHASE4)
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:
- E. coli Nissle suspension CI brief — competitive landscape report
- E. coli Nissle suspension updates RSS · CI watch RSS
- University of Hohenheim portfolio CI