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Mixture of three Bifidobacteria
A mixture of three Bifidobacteria strains restores beneficial gut microbiota composition to promote intestinal health and immune function.
A mixture of three Bifidobacteria strains restores beneficial gut microbiota composition to promote intestinal health and immune function. Used for Dysbiosis and gastrointestinal disorders (specific indications not fully characterized in available literature).
At a glance
| Generic name | Mixture of three Bifidobacteria |
|---|---|
| Also known as | Bifidobacterium infantis M-63® breve M-16V® longum BB536® |
| Sponsor | Federico II University |
| Drug class | Probiotic |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | FDA-approved |
Mechanism of action
Bifidobacteria are commensal bacteria that colonize the colon and produce short-chain fatty acids, particularly butyrate, which strengthen the intestinal barrier, reduce pathogenic bacterial overgrowth, and modulate local and systemic immune responses. This probiotic mixture aims to restore eubiotic balance in dysbiotic conditions, improving gastrointestinal symptoms and potentially enhancing overall health outcomes.
Approved indications
- Dysbiosis and gastrointestinal disorders (specific indications not fully characterized in available literature)
Common side effects
- Gastrointestinal disturbance
- Bloating
- Flatulence
Key clinical trials
- Bifidobacteria In Children With Abdominal Pain-Associated Functional Gastrointestinal Disorders (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:
- Mixture of three Bifidobacteria CI brief — competitive landscape report
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- Federico II University portfolio CI