Clinical Experience: Adult
The formulation contained in Visbiome® (the "De Simone Formulation") was invented in the 1990's by Professor Claudio De Simone, M.D.
Clinical Experience - Irritable Bowel Syndrome (IBS) Dietary Management
The De Simone Formulation has been the subject of over 60 published clinical trials in human subjects, with extensive clinical research in the dietary management dysbiosis associated with irritable bowel syndrome (IBS), ulcerative colitis (UC), pouchitis, and hepatic encephalopathy (HE).
The De Simone Formulation has been the subject of clinical trials involving over 250 adult and pediatric patients in the dietary management of dysbiosis associated with IBS. 22,23,24,25 In one study, 25 patients with diarrhea-predominant IBS received placebo or the De Simone Formulation for eight weeks. Patients receiving the probiotic experienced a statistically significant reduction in abdominal bloating.23 In a second study, 48 patients with Rome II IBS were randomized in a double-blind design to the probiotic or placebo. Patients receiving the De Simone Formulation experienced a statistically significant reduction in flatulence (p=0.01).22 The De Simone Formulation was well tolerated with no adverse events reported in either IBS studies.
Clinical Experience - Ulcerative Colitis (UC) Dietary Management
The De Simone Formulation has been the subject of published clinical studies in ulcerative colitis involving nearly 500 adult and 47 pediatric patients.26,27,28,29,30 In these studies, the daily consumption of the De Simone Formulation was associated with effective dietary management of ulcerative colitis.
In one study, involving 90 adult patients, the De Simone Formulation plus low-dose balsalazide was compared to balsalazide, or mesalamine alone in the dietary management of acute ulcerative colitis. The De Simone Formulation plus low-dose balsalazide was superior to balsalazide and mesalamine alone in achieving dietary management of remission (85.7% vs. 80.8% vs. 72.7%; p<0.02), with improved time to remission (4 days vs. 7.5 vs. 13; p<0.001).27 In a second study involving 32 adult patients with acute UC, dietary management with the De Simone Formulation resulted in a combined 77% remission/response rate with no adverse effects, as
measured by UCDAI score (53% remission, 24% response).26
In the dietary management of ulcerative colitis (UC), the De Simone Formulation was also shown to help achieve remission when added to standard therapies (mesalazine, azathioprine, or 6-mercaptopurine). In a multicenter, randomized, double-blind, placebo- controlled trial (n=147) patients consuming the De Simone Formulation had significantly higher remission rates vs. placebo (43% vs. 16%; p< 0.001). In the same study, UCDAI scores showed a significant decrease by 50% from baseline (p<0.001).29
Clinical Experience - Pouchitis Dietary 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 pouchitis.31,32,33 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 (p<0.001).31 The formulation found in VISBIOME is recognized as an effective tool for the dietary management of pouchitis by the American College of Gastroenterology,34 German Association of Gastroenterology,35 the British Society of Gastroenterology,36 the European Crohn’s and Colitis Organization (ECCO)37, and The Cochrane Collaboration.38
Clinical Experience - Hepatic Encephalopathy (HE) Dietary Management
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.39,40,41,42 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 vs. 14 in the control group (p<0.05).42 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. There was a significant difference in the development HE in the probiotic vs. no treatment groups (p=0.02) and in the lactulose vs. no treatment group (p=0.001) but no difference between the probiotic group vs. lactulose (p=0.134).40