Post Marketing Pipeline - Human
Visbiome® probiotic products are currently the subject of several post-marketing trials evaluating the formulation in a number of human and veterinary applications. Visbiome is commercialized as a medical food in the U.S. and is approved by Health Canada as a Natural Health Product (NPN 80061901). Visbiome is not an FDA approved drug product.
| Disease State | Primary Endpoint | Sponsor/Collaborator | Trial Design | Estimated Enrollment |
|---|---|---|---|---|
| Multiple Sclerosis | Peripheral Blood Mononuclear Cells (pBMCs), Serum Neurofilament Light Concentration | Columbia University & University of Pittsburg | Controlled vs Prebiotic | 20 |
| Newly Diagnose Type 1 Diabetes | Effect of Multistrain Probiotic on Immune System Inflammation as measured by plasma transcription analysis | Medical College of Wisconsin | Single Blind Placebo Controlled | 60 |
| HIV | Blood immune activation -Percent change in blood immune activation (co-expression of CD38 and HLA-DR) on CD8 T cells at week 48 | Canadian HIV Trials Network | Double Blind Placebo Controlled | 40 |
| Autism Spectrum Disorders | Changes in severity level of ASD symptomatology, Delta of scores at Autism Diagnostic Observation Schedule-2 | IRCCS Stella Maris Foundation, Ministry of Health Italy, CNR Institute of Clinical Physiology | Double Blind Placebo Controlled | 100 |
| Autism Spectrum Disorder | Change in Autism Treatment Evaluation Checklist (ATEC) — 12 weeks of treatment | University College, London | Double Blind Placebo Controlled | 82 |
| Cirrhosis plus Spontaneous Bacterial Peritonitis | Changes in bacterial translocation. Changes in systemic inflammatory response and systemic oxidative damage. Changes in cognitive function. | Foundation Research Institute of the Hospital de Sant Pau, Barcelona Spain | Double Blind Placebo Controlled** | 30 |
| Pre-Diabetic Adolescents | Change in microbiota composition | University of Seattle | Double Blind Placebo Controlled | 16 |
| Eradication of Extended Spectrum BetaLactam (ESBL) colonization in adult | Rate of participants that have changed from ESBL-negative to ESBL-negative. | Lund University | Double Blind Placebo Controlled | 80 |
| Portal Hypertension | Nocturnal systolic blood pressure – 8 weeks | Charite University, Berlin, Germany | Double Blind Placebo Controlled | 110 |
| Severe Depression | Hamilton Depression Score | University Psychiatric Clinics, Basel, Switzerland | Double Blind Placebo Controlled | 60 |
Post Marketing Pipeline - Animal
Visbiome® Vet is a high potency veterinary probiotic for pets which is used to support normal inflammatory responses in the GI tract and to help maintain gut health. Visbiome Vet is a veterinary nutritional supplement and not an FDA approved drug
| Disease State | Primary Endpoint | Sponsor/Collaborator | Trial Design | Estimated Enrollment |
|---|---|---|---|---|
| Canine Inflammatory Bowel Disease | Dogs with IBD were randomized to receive either probiotic or combination drug therapy (Metronidazole/prednisone). Evaluation with histology, CIBDAI, CD3+ cells, FoxP3+ cells, plasma, citrulline, microbiota analysis. | Texas A&M University, Iowa State University, University of Camerino (Italy) | Double Blind Randomized-Controlled | 34 Dogs |
| Acute Hemorrhagic Diarrhea Syndrome (canine) | To evaluate the efficacy of probiotics in the treatment of acute hemorrhagic diarrheal syndrome in dogs and to characterize the changes in bacterial microbiota during the course of disease. | University of Munich | Controlled | 60 Dogs |