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:
- Irritable Bowel Syndrome (IBS)
- Ulcerative Colitis (UC)
- Antibiotic-Associated Diarrhea (AAD)
- Pouchitis
- Hepatic Encephalopathy (HE)
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
IIn 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 the Dietary Management of Pouchitis
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 pouchitis.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 | Sponsor/Collaborator | Trial Design | Estimated Enrollment |
|---|---|---|---|---|
| Multiple Sclerosis | Peripheral Blood Mononuclear Cells (pBMCs), Serum Neurofilament Light Concentration | Columbia University & University of Pittsburg | Controlled vs prebiotic | 20 |
| Newly Diagnosed Type 1 Diabetes | Effect of Multi-strain Probiotic on Immune System Inflammation as measured by plasma transcription analysis | Medical College of Wisconsin | Single Blind Placebo Controlled | 60 |
| HIV Alcohol Liver study | How the microbiome effects AUD and ALD | University of California, Los Angeles | Pilot randomized placebo controlled | 80 |
| HPV HIV | TBD - Reduction in anal HPV | University of California San Francisco | Open Label | TBD |
| PLWH (HIV) alcohol-associated GI dysbiosis in heavy alcoholic drinkers | Dysbiosis ratio, biomarkers of microbial translocation and inflammation, CV risk, and mortality risk | University of Louisville in conjunction with the University of Florida | Randomized Controlled Trial | 250 |
| Depression | Improvement of adolescent depression | University of California, San Francisco | Pilot study | 21 |
| 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 |
| Autism Spectrum Disorder | Change in Autism Treatment Evaluation Checklist (ATEC) | University College, London | Double Blind Placebo Controlled - Crossover | 82 |
| Eradication of Extended Spectrum Beta Lactam (ESBL) colonization in adult | Rate of participants that have changed from ESBL-positive to ESBL-negative | Lund University | Double Blind Placebo Controlled | 80 |
| Portal Hypertension | Nocturnal systolic blood pressure | Charite University, Berlin Germany | Double Blind Placebo Controlled | 110 |
Human Studies – SivoBiome™
SivoBiome™ is under clinical development but not currently commercially available in the U.S.
| Disease State | Primary End Point | Sponsor/Collaborator | Trial Design | Estimated Enrollment |
|---|---|---|---|---|
| Sivobiome™ Probiotic in Moderate Covid-19 Positive Patients Pre-ICU | Resolution of diarrhea. Progression to intubation , mortality, length of hospital stay. Patients treated concomitantly with conventional treatments (chloroquine, antibiotics, biologics) | University of Roma La Sapienza – Italy | Controlled vs standard of care without probiotic | 70 |
| Sivobiome™ and oxygen-ozone as adjuvant in early control of Covid-19 Progression | Progression to intubation despite treatment, mortality, length of hospital stay | Roma La Sapienza – Italy of Wisconsin | Controlled vs standard of care without probiotic/oxygen ozone therapy | 152 |
Veterinary Studies
| Disease State | Primary End Point | Sponsor/Collaborator | Trial Design | Estimated Enrollment |
|---|---|---|---|---|
| Intestinal inflammation and fecal dysbiosis | Canine Esomeprazole/Probiotic study (effect of probiotic admin. on fecal dysbiosis and intestinal inflam. Secondary to Esomeprazole admin in healthy dogs) | University of Wisconsin | Prospective, sequential study | 14 |
| Hepatic Encephalopathy | HE clinical signs and blood ammonia levels | University of Georgia | Control vs Metronidazole | 20 |
| Canine Epilepsy | Effect of probiotic on seizure frequency and microbiome in idiopathic epilepsy receiving anti-epileptic drugs | University of Wisconsin | Placebo-controlled, double-blinded, cross-over | 30 |
| Chronic Intermittent Diarrhea/evaluation of microbiome and fecal consistency in captive gibbons | Evaluate changes to the microbiome and fecal consistency over time after probiotic treatment and identify taxa that may be involved in chronic intermittent diarrhea in captive gibbons | Gibbon Conservation Center | Multi-year study | 37 |
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