Status:
TERMINATED
The Use of VSL#3 in Irritable Bowel Syndrome in Children
Lead Sponsor:
Dayton Children's Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
13-18 years
Phase:
PHASE1
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 child...
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 C...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00932841
Start Date
January 1 2008
End Date
August 1 2011
Last Update
March 20 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Medical Center of Dayton
Dayton, Ohio, United States, 45404