Canada
Subjective global relief of symptoms
Significantly better with probiotic vs. placebo
(p < 0.05)
Visbiome in the Dietary Management of Pediatric IBS & UC
The De Simone Formulation found in Visbiome has been the subject of 1 clinical study in pediatric IBS [[[Guandalini et al. Journal of Pediatric Gastroenterology and Nutrition. 2010;51:24-30]]](((Visbiome.com))) and 2 studies in pediatric UC[[[Miele E, et al. American Journal of Gastroenterology. 2009;104:437–443.]]](((Visbiome.com)))[[[Huynh Hien Q, et al. Inflamm Bowel Dis 15: 760-768 (2009)]]](((Visbiome.com)))
Key Outcomes
Pediatric Irritable Bowel Syndrome
Guandalini et al. (2010)
Key Outcomes as a Medical Food
Abdominal pain/discomfort
Reduced significantly (p < 0.05)
Bloating/gassiness
Significantly improved (p < 0.05)
Family life disruption
Significantly reduced (p < 0.01)
Adverse events
None reported – probiotic was well tolerated
Population
59 children ages 4-18 with IBS
7 Clinical Centers including U of Chicago
Trial Design
Multicenter, randomized, double-blind, placebo-controlled crossover design
6 weeks of evaluation period with 2-week washout
Key Outcomes
Pediatric Ulcerative Colitis
Miele et al. (2009)
Key Outcomes as a Medical Food (Visbiome + 5ASA/Corticosteroids)
Remission maintenance
3 of 14 (21.4 %) patients on Visbiome + concomitant therapy and 11 of 15 (73.3 %) patients on placebo relapsed within 1 year of follow-up (p = 0.014)
PUCAI scores
Significant reductions
Fecal calprotectin
Significant reductions
Adverse events
None reported – probiotic was well tolerated
Population
29 children ages 1.7-16 with UC
All patients also receiving standard therapy (5ASA + corticosteroids)
Trial Design
Randomized, double-blind, placebo-controlled trial
Visbiome’s formula is a proven complement to standard therapy.
79%
Maintenance of remission