Clinical Experience: Pediatric

Clinical Experience in Children

The De Simone Formulation was the subject of two trials involving patients between the ages of 1.7 and 17 years of age with active ulcerative colitis (UC). In one 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. four patients (36.4%) in placebo arm (p<0.001). In addition, 21.4% of patients consuming the De Simone Formulation and standard UC therapy and 73.3 % patients consuming placebo and standard therapy relapsed within 1 year of follow-up (p= 0.014). At six months, 12 months, or at time of relapse, endoscopic and histological scores were lower in the probiotic group than in placebo group.29

In a second study in pediatric patients with mild to moderate acute UC, the De Simone Formulation was administered open-label for eight weeks. 13 patients (56%) achieved remission and the combined remission/response rate was 61%.43

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.44

Randomized Condition

Results

Dietary Management With De Simone Formulation 

(14 patients total)

  • 13 patients achieved remission
  • 3 patients 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 achieved remission
  • 11 patients relapsed within 1 year of follow-up

Please Note

This area of visbiome.com is intended for use by healthcare professionals only.

I am a Healthcare Professional. I am NOT a Healthcare Professional.

Please Note

You are now leaving Visbiome.com (USA) for Visbiome Canada.

Proceed to Visbiome Canada Stay on the US site