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

Phase 1

Terminated

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: VSL#3 900 billion bacteria; Other: Placebo; Drug: VSL#3 90 billion bacteria

• Registration Number: NCT00932841
• Lead Sponsor: Dayton Children's Hospital

Brief 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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2009-07-02
• Study First Submitted QC: 2009-07-02
• Study First Posted: 2009-07-03
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-16
• Last Update Posted: 2012-03-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• All children should fulfill Rome ll criteria for IBS.
• Organic disease has been excluded.
• Age 13-18 years.
• Have active symptoms for at least 2 weeks prior to randomization. A minimum of 4.0 on the 7-point Likert scale for the two weeks prior to randomization on the GSRS-IBS composite pain score will be required.
• Diarrhea predominant IBS: Diarrhea is defined as increased stool frequency more than 3 times daily or change in form to loose or watery stools.

Exclusion Criteria

• Children not fulfilling the inclusion criteria.
• Children receiving medication for the treatment of irritable bowel syndrome within 2 weeks of randomization.
• Children receiving antibiotic therapy or other probiotic agents within 4 weeks of randomization.
• Children receiving other medication known to cause abdominal pain.
• Children diagnosed with any of the following GI disorders: IBD (Crohn's disease or UC), Celiac disease, Gastroparesis, abdominal adhesions, Gastrointestinal perforation, Gastrointestinal obstruction and/or stricture, chronic or recurrent pancreatitis.
• Children who had undergone previous abdominal surgery (with the exception of uncomplicated appendectomy or cholecystectomy greater than or equal to 6 months prior to enrollment).
• Children with a history of any disease that may affect bowel motility such as diabetes mellitus, or poorly controlled hypo/hyperthyroidism.
• Children with immune deficiency, on immune-suppressants, or have active psychiatric, neurological, metabolic, renal, hepatic, infectious, hematological, cardiovascular or pulmonary disease.
• Children with a history of malignancy.
• Pregnancy.
• Children with history of allergy to maize or probiotics.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VSL#3 900 billion bacteria	VSL#3 900 billion bacteria	-
Placebo	Placebo	-
VSL#3 90 billion bacteria	VSL#3 90 billion bacteria	-

Primary Outcome Measures

Name	Time	Method
The Gastrointestinal Symptom Rating Scale	8 weeks

Secondary Outcome Measures

Name	Time	Method
Coddington life events questionnaire	8 weeks

Trial Locations

Locations (1)

Children's Medical Center of Dayton; 🇺🇸 Dayton, Ohio, United States