NCT00793494

Efficacy of Probaclac in Irritable Bowel Syndrome in Children Aged 8 to 18 Years

Randomized Controlled Trial of Probaclac Versus Placebo in Children Aged 8 to 18 Years With Irritable Bowel Syndrome

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: St. Justine's Hospital · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to determine the efficacy of the administration of Bifidobacterium bifidum R0071, Bifidobacterium longum R0175, Lactobacillus helveticus R0052, Lactobacillus Delb. SSP bulgaricus R9001, Lactobacillus rhamnosus R0011, Lactococcus Lactis SSP. lactis R1058 et Streptococcus thermophilus (Probaclac™) given twice a day for 4 weeks on digestive symptoms evaluated subjectively in children aged 8 to 18 years with irritable bowel syndrome versus placebo. This study is a double-blind randomized controlled study. 84 children will included. After inclusion, a 15-day period of observation precedes the randomization at Day 0. Patients receive Probaclac or placebo for 4 weeks. At the end of the treatment period, patients are followed for a 2-week period of follow-up. 4 visits and 4 phone calls are planned during the study.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
OTHER	Probaclac	Bifidobacterium bifidum R0071, Bifidobacterium longum R0175, Lactobacillus helveticus R0052, Lactobacillus Delb. SSP bulgaricus R9001, Lactobacillus rhamnosus R0011, Lactococcus Lactis SSP. lactis R1058 et Streptococcus thermophilus (Probaclac™)
OTHER	Placebo	Placebo composition matodextrin, gelatin, ascorbic acid, soya

Timeline

• Start date: 2009-01-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2008-11-19
• Last updated: 2016-04-13

Locations

1 site across 1 country: Canada