Visbiome Pipeline

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

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