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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Other: Placebo
* Drug: VSL#3 900 billion bacteria
* Drug: VSL#3 90 billion bacteria


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* One packet PO daily x 8 weeks.<br>* Other names: VSL#3;|
| Active Comparator: VSL#3 90 billion bacteria<br> | Drug: VSL#3 90 billion bacteria<br>* One packet PO daily, x 8 weeks.<br>* Other names: VSL#3;|
| Active Comparator: VSL#3 900 billion bacteria<br> | Drug: VSL#3 900 billion bacteria<br>* One packet PO daily, x 8 weeks<br>* Other names: VSL#3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Gastrointestinal Symptom Rating Scale |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coddington life events questionnaire |  | 8 weeks |