Canada
Visbiome Pipeline - Old
ExeGi is focused on research and development of microbiome science and expanding the use of Visbiome in a variety of therapeutic areas.
Human Studies
|
Disease State |
Primary Endpoint |
Sponsor/Collaborator |
Trial Design |
Estimated Enrollment |
|---|---|---|---|---|
| Multiple Sclerosis | Pripheral Blood Mononuclear Cells (pBMCs), Serum Neurofilament Light Concentration | Newly Diagnose Type 1 Diabetes | Controlled vs prebiotic | 20 |
| Newly Diagnose Type 1 Diabetes | Effect of Multistrain Probiotic on Imnune 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 Disorder |
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 | 110 |
|
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 Change in microbiota composition (Secondary) |
University of Settle | 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 |
*This project is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) under cooperative agreement UA3 MC11054 – Autism Intervention Research Network on Physical Health. This information or content and conclusions are those of the author and should not be construed as the official position or policy of, nor should any endorsements be inferred by HRSA, HHS or the U.S. Government. This work is being conducted through the Autism Speaks Autism Treatment Network serving as the Autism Intervention Research Network on Physical Health.
**Clinical product reported as Vivomixx(r). The De Simone Formulation under evaluation in these reported studies is available as Visbiome® in the U.S. and Vivomixx in Europe.
Veterinary Studies
|
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 |