NCT00932841

The Use of VSL#3 in Irritable Bowel Syndrome in Children

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Dayton Children's Hospital · Academic / Other
• Sex: All
• Age: 13 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to determine whether the oral administration of the probiotic VSL#3 under randomized, placebo-controlled conditions will improve symptoms of irritable bowel syndrome in children, safely.

Detailed description

Determine the safety and efficacy of different doses of VSL#3 in the treatment of children with irritable bowel syndrome: Children will be recruited from the pediatric gastroenterology clinic at The Children's Medical Center in Dayton, Ohio. Eighty four children will be enrolled in this controlled, double-blinded, randomized study. All children will have had a prior evaluation by a pediatric gastroenterologist who has diagnosed these patients with irritable bowel syndrome and excluded organic disease as a cause of the child's abdominal pain.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
OTHER	Placebo	One packet PO daily x 8 weeks.
DRUG	VSL#3 900 billion bacteria	One packet PO daily, x 8 weeks
DRUG	VSL#3 90 billion bacteria	One packet PO daily, x 8 weeks.

Timeline

• Start date: 2008-01-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2009-07-03
• Last updated: 2012-03-20

Locations

1 site across 1 country: United States