Irritable Bowel Syndrome
Conditions
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 children, safely.
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 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.
Interventions
OTHERPlacebo
One packet PO daily x 8 weeks.
DRUGVSL#3 900 billion bacteria
One packet PO daily, x 8 weeks
DRUGVSL#3 90 billion bacteria
One packet PO daily, x 8 weeks.
Sponsors
National Institutes of Health (NIH)
Dayton Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Gastrointestinal Symptom Rating Scale | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Coddington life events questionnaire | 8 weeks |
Countries
United States
Outcome results
None listed