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

Dayton Children's Hospital

Status and phase

Terminated

Phase 1

Conditions

Irritable Bowel Syndrome

Treatments

Drug: VSL#3 90 billion bacteria

Drug: VSL#3 900 billion bacteria

Other: Placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00932841

04-007

R21AT003400-01A2 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

13 to 18 years old

Volunteers

No Healthy Volunteers

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.