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 |
|---|---|---|---|
| HIV patients and cardiovascular disease | Dysbiosis, microbial translocation, and cardiovascular risk | Vanderbilt University | Randomized placebo-controlled trial |
| Gut, Liver, and Metabolome in HIV Patients | Plasma metabolome, Intestinal dysbiosis, measurement of bacterial translocation, measurements of hepatic steatosis and adipose tissue density and volume | Vanderbilt University | Pilot trial |
| Bile Acid Diarrhea | Bile acid malabsorption/diarrhea unassociated with ileal resection | Mayo Clinic | Randomized placebo-controlled trial |
| PLWH (HIV) alcohol-associated gastrointestinal dysbiosis in heavy alcoholic drinkers | Dysbiosis ratio, biomarkers of microbial translocation and inflammation, cardiovascular risk, and mortality risk | University of Louisville in conjunction with the University of Florida | Randomized placebo-controlled trial |
| Depression | Improvement of adolescent depression scores | University of California, San Francisco | Randomized placebo-controlled trial |
| HIV and Alcoholic Liver Disease | Evaluate the feasibility and acceptability of administering a probiotic among those living with HIV and heavy drinking, look at changes in the gastrointestinal microbiome characteristics and cardiovascular disease-related serum biomarkers | University of Florida | Pilot trial |
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 | Collaborator/Sponsors | Trial Design |
|---|---|---|---|
| Chronic Kidney Disease in Cats | Reduction of serum indoxyl sulfate concentration and preservation of renal function | Iowa State University, College of Veterinary Medicine | Placebo Controlled Trial |
| Chronic Kidney Disease in Cats | Assess the impact of daily administration of a probiotic on the GI microbiome, serum IS and pCS concentrations and phosphate homeostasis in cats with CKD during a randomized, cross-over trial. | Michigan State University | Placebo Controlled Crossover |