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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome

In brief

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.

Key facts

Study ID

NCT00932841

Run by

Dayton Children's Hospital

People needed

15

Starts

2008-01-01

Expected to finish

2011-08-01

Last updated by the study team

2012-03-20

Who can join

Age: 13 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Medical Center of Dayton — Dayton, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.