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

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 onthe 7-point Likert scale for the two weeks prior to randomization on the GSRS-IBScomposite pain score will be required.

• Diarrhea predominant IBS: Diarrhea is defined as increased stool frequency more than 3times 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 2weeks of randomization.

• Children receiving antibiotic therapy or other probiotic agents within 4 weeks ofrandomization.

• Children receiving other medication known to cause abdominal pain.

• Children diagnosed with any of the following GI disorders: IBD (Crohn's disease orUC), 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 ofuncomplicated appendectomy or cholecystectomy greater than or equal to 6 months priorto enrollment).

• Children with a history of any disease that may affect bowel motility such as diabetesmellitus, or poorly controlled hypo/hyperthyroidism.

• Children with immune deficiency, on immune-suppressants, or have active psychiatric,neurological, metabolic, renal, hepatic, infectious, hematological, cardiovascular orpulmonary disease.

• Children with a history of malignancy.

• Pregnancy.

• Children with history of allergy to maize or probiotics.