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