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

• Status: Terminated
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dayton Children's Hospital
• Collaborator: National Institutes of Health (NIH)

Criteria

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.