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Lcr Regenerans
Lcr Regenerans is a live biotherapeutic product designed to restore and regenerate the gut microbiota composition.
Lcr Regenerans is a live biotherapeutic product designed to restore and regenerate the gut microbiota composition. Used for Microbiota restoration in dysbiosis-related conditions (specific indication under investigation in Phase 3).
At a glance
| Generic name | Lcr Regenerans |
|---|---|
| Also known as | GYNOPHILUS |
| Sponsor | Probionov |
| Drug class | Live biotherapeutic product (LBP) |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology / Immunology |
| Phase | Phase 3 |
Mechanism of action
The drug consists of a defined consortium of beneficial bacterial strains intended to restore dysbiotic microbiota to a healthy state. By recolonizing the intestinal tract with specific probiotic organisms, it aims to restore microbial diversity and function, thereby improving barrier integrity and reducing pathogenic overgrowth. This microbiota restoration may have downstream effects on immune homeostasis and intestinal health.
Approved indications
- Microbiota restoration in dysbiosis-related conditions (specific indication under investigation in Phase 3)
Common side effects
- Gastrointestinal disturbances
- Abdominal discomfort
- Diarrhea
Key clinical trials
- Treatment of the Intermediate Vaginal Microbiota With Vaginal Lactobacillus Casei Rhamnosus to Improve Pregnancy Outcome (PHASE3)
- Study Evaluating the Optimal Dosage for Equivalence Between Lcr Regenerans® Capsules and Tablets (Lactobacillus Rhamnosus Lcr35®) on the Vaginal Flora Colonisation (PHASE1)
- Study of the Efficacy and Tolerance of Intra-vaginal Treatment With a Total Freeze-dried Culture of Lcr Regenerans® in the Prevention of Relapses of Recurrent Vulvovaginal Candidiasis (PHASE3)
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 |