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The Critical Nature of Research

The human gastrointestinal (GI) tract is home to trillions of organisms which form the complex bacterial community known as the gut microbiome.

Probiotics may increasingly be a key factor in protecting this intricate network from the disastrous effects of disease.

However, formulas vary. Successes will ultimately depend on the bacterial strains utilized, the concentration of bacteria, the way in which strains are processed, and the quality of the strains used.  

The Impact of Visbiome®

Visbiome is a highly concentrated, high potency probiotic mix of eight bacterial strains that has proven successful in the dietary management of conditions including:

Visbiome and the Dietary Management of Irritable Bowel Syndrome (IBS)

The De Simone Formulation has been the subject of clinical trials involving more than 370 adult and pediatric patients in the dietary management of dysbiosis associated with IBS.22, 23, 24, 25

    IBS Study 1

For eight weeks, 25 patients with diarrhea-predominant IBS received a placebo or the De Simone Formulation.

Patients receiving the probiotic experienced a statistically significant reduction in abdominal bloating.23   

    IBS Study 2

Forty-eight patients with Rome II IBS were randomized in a double-blind design to the probiotic or placebo.

Those who received the De Simone Formulation experienced a statistically significant reduction in flatulence.22 

The De Simone Formulation was well tolerated with no adverse events reported in either study. 

Visbiome restores Bifidobacterium in patients who are on the low FODMAP diet. In a clinical study: The low FODMAP diet led to a reduction in Bifidobacterium in the stool. Co-administration of Visbiome increased the numbers of Bifidobacterium species, compared to the low FODMAP Diet alone.

Visbiome and the Dietary Management of Ulcerative Colitis (UC)

Daily consumption of the De Simone Formulation has been associated with the effective dietary management of ulcerative colitis following published clinical trials involving nearly 500 adult and 47 pediatric patients. A notable study involving 32 adult patients with acute ulcerative colitis yielded a combined 77% remission/response rate with no adverse effects, as measured by Ulcerative Colitis Disease Activity Index (UCDAI) score.

    Ulcerative Colitis Study 1

In a study involving 90 adult patients, the De Simone Formulation plus a low dose of the anti-inflammatory drug balsalazide proved superior to both balsalazide and mesalamine by themselves in achieving dietary management of remission and improving time to remission. 27   

    Ulcerative Colitis Study 2

A second study involving 32 adult patients with acute ulcerative colitis yielded a combined 77% remission/response rate with no adverse effects, as measured by Ulcerative Colitis Disease Activity Index (UCDAI) score.26 

In the dietary management of ulcerative colitis:  

  • The De Simone Formulation helped achieve remission when added to standard therapies such as mesalazine, azathioprine, or 6-mercaptopurine.
  • In a multicenter, randomized, double-blind, placebo- controlled trial, patients consuming the De Simone Formulation had significantly higher remission rates vs. placebo (43% vs. 16%). In the same study, UCDAI scores showed a significant decrease by 50% from baseline.29

Visbiome and the Dietary Management of Antibiotic-Associated Diarrhea

In a controlled clinical trial, the formulation in Visbiome was shown to support patients consuming antibiotics.1 None of the patients that received the Visbiome Formulation while being treated with antibiotics presented with diarrhea, while 11.4% of patients that received the placebo experienced diarrhea. The length of hospitalization of the patients that received the De Simone Formulation was also shorter than patients that received the placebo; 6.7 vs 8.7 days.

Visbiome and Ileal-Pouch Management

In three double-blind, placebo-controlled trials and one open trial, the De Simone Formulation has been shown to aid in the dietary management of the  Ileal-Pouch.31-33

  • In Gionchetti et al. (2000), 40 patients with chronic relapsing pouchitis were randomized to the probiotic or placebo after one month of antibiotic treatment. In the dietary management of remission, 20 patients consuming the probiotic were still in remission after nine months compared to zero in the placebo group.
  • The De Simone Formulation has since been recognized as an effective tool for the dietary management of pouchitis by the American College of Gastroenterology, the German Association of Gastroenterology, the British Society of Gastroenterology, the European Crohn’s and Colitis Organization (ECCO), and The Cochrane Collaboration.34-37

Visbiome and the Dietary Management of Hepatic Encephalopathy (HE)

In the dietary management of dysbiosis associated with hepatic encephalopathy (HE), the De Simone Formulation has been the subject of multiple controlled clinical studies involving over 750 patients. In one placebo-controlled trial involving 160 cirrhotic patients, those consuming the De Simone Formulation for dysbiosis experienced a reduced incidence of HE, reduced ammonia levels, and improvements in psychometric test compared to controls. 

    Hepatic Encephalopathy Study 1

In one placebo-controlled trial involving 160 cirrhotic patients, those consuming the De Simone Formulation for dysbiosis experienced a reduced incidence of HE, reduced ammonia levels, and improvements in psychometric test compared to controls. Seven patients in the probiotic group experienced overt HE compared to 14 in the control group.  

    Hepatic Encephalopathy Study 2

In a second study, 235 cirrhotic patients who had prior episodes of HE were evaluated after consuming the De Simone Formulation, lactulose, or no therapy whatsoever. There was a significant difference in the development of HE in the probiotic vs. no treatment groups and in the lactulose vs. no treatment group, but no difference between the probiotic group vs. lactulose. 

Pediatric Advances  

The De Simone Formulation has been the subject of two trials involving patients between the ages of 1.7 and 17 years of age with active ulcerative colitis (UC), and another involving patients with IBS.

• In the first trial, 29 patients were randomized to receive dietary management with the De Simone Formulation or placebo concomitantly with standard UC treatment (steroids, 5-ASA). Of the 29 patients, 92.8% of those treated with the De Simone Formulation and standard therapy achieved remission vs. 36.4% in the placebo arm.

Randomized Condition Results

Dietary Management with De Simone Formulation (14 patients total)

• 13 patients (92.8%) achieved remission

• 3 patients (21.4%) relapsed within 1 year of follow-up

• At 6 months, 12 months, and at time of relapse endoscopic and histological scores were significantly lower than placebo group.

Placebo Concomitantly with Standard UC Treatment (steroids, 5-ASA)

(15 patients total)

• 4 patients (36.4%) achieved remission.

• 11 patients (73.3%) relapsed within 1 year of follow-up

• In the second study in pediatric patients with mild-to-moderate acute UC , the De Simone Formulation was administered open-label for eight weeks.

o Thirteen patients (56%) achieved remission.
o The combined remission/response rate was 61%. 

• A third open-label study was conducted in 59 pediatric patients with irritable bowel syndrome (IBS). In this study, probiotics reduced the intensity and frequency of abdominal pain and bloating after six weeks.

Further research into such disease states will help scientists better understand their connectivity and the way Visbiome could potentially help to restore a healthy microbiome ecology.

clinical trials

ExeGi is focused on research and development of microbiome science and expanding the use of Visbiome in a variety of therapeutic areas

Human Studies - Visbiome

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

Veterinary Studies

Disease State Primary End Point Collaborators/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
Fecal dysbiosis and intestinal inflammation Effect of probiotic administration on fecal dysbiosis and intestinal inflammation secondary to Esomeprazole administration in healthy dogs University of Wisconsin Prospective, sequential study
Canine Epilepsy Effect of probiotic on seizure frequency and microbiome in dogs with idiopathic epilepsy receiving anti-epileptic drugs University of Wisconsin Placebo-controlled, double-blinded, cross-over
Chemotherapy induced diarrhea Administration of probiotic for the management of chemotherapy induced diarrhea in dogs undergoing CHOP therapy University of Wisconsin Placebo Controlled
Acute Gastroenteritis Efficacy of diet, antibiotics, or probiotics for the treatment of canine acute gastroenteritis University of Tennessee College of Veterinary Medicine Controlled Trial
Hepatic Encephalopathy Hepatic Encephalopathy clinical signs and blood ammonia levels University of Georgia Controlled Trial

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