Development Pipeline
ExeGi is focused on research and development of microbiome science and expanding the use of Visbiome in a variety of therapeutic areas.
| Disease State | Primary End Point | Collaborators/Sponsors | Trial Design |
|---|---|---|---|
| Multiple Sclerosis | Peripheral Blood Mononuclear Cells (pBMC’s), Serum Neurofilament Light Concentration | Columbia University and the University of Pittsburgh | Controlled Trial |
| Newly Diagnosed Type I Diabetes | Effect of Multi-Strain Probiotic on Immune System Inflammation as measured by plasma transcription analysis | Medical College of Wisconsin | Single-Blinded Placebo-Controlled |
| HIV and Alcoholic Liver | How the microbiome effects AUD and ALD | University of California, Los Angeles | Pilot & Randomized Placebo-Controlled |
| 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 Controlled Trial |
| Depression | Improvement of adolescent depression scores | University of California, San Francisco | Pilot Study and Randomized Placebo-Controlled |
| HIV and Alcoholic Liver Disease | Evaluate the feasibility and acceptability of administering a 3-month food-based 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 Study |
| physiological and psychological stress responses | to determine the efficacy of probiotic therapy on the physiologic and psychological stress responses among direct-care nurses | The Ohio State University | Quasi-experimental |
| Cirrhosis plus Spontaneous bacterial peritonitis | Looking at 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 Blinded Placebo Controlled |
| Autism Spectrum Disorder | Changes in Autism Treatment Evaluation Checklist (ATEC) | University College, London | Randomized, controlled cross-over study |
| Eradication of Extended Spectrum Beta Lactam (ESBL) | colonization in adults Rate of participants that have changed from ESBL-positive to ESBL-negative | Lund University | Randomized, Placebo-Controlled, Single Blinded Study |
| Portal Hypertension | Effect of probiotic on nocturnal systolic blood pressure | Charite University, Berlin Germany | Exploratory, randomized, double-blinded, placebo-controlled, parallel-group study |
| Frailty In Cirrhosis | Mortality during hospitalization and follow-up, Frailty in Patients With Cirrhosis: Prognostic Value of the Phase Angle in Hospitalized Patients and Effect of Multifactorial Intervention (home exercise, branched-chain amino acids and probiotic) | Foundation Research Institute of the Hospital de Sant Pau, Barcelona Spain | Open-Label |
| Bacterial Translocation | Effect of Probiotic on Gut Microbiome and Bacterial Translocation in Healthy Asian Volunteers | Changi General Hospital, Singapore | Partially-Blinded Study |
*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.
