Overview

This trial is active, not recruiting.

Condition irritable bowel syndrome
Sponsor Medical College of Wisconsin
Start date June 2007
End date June 2013
Trial size 17 participants
Trial identifier NCT00677976, CHW 06/163

Summary

The purpose of the study is to map regions of brain activation following rectal stimulation in children with irritable bowel syndrome (IBS) and healthy controls.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Children between the ages of 10 and 18 who meet Rome III criteria for IBS as determined by a pediatric gastroenterologist.
Healthy children between the ages of 10 and 18.

Primary Outcomes

Measure
We intend to measure the degree of brain activation following rectal stimulation
time frame: 4 years

Eligibility Criteria

Male or female participants from 10 years up to 18 years old.

Inclusion Criteria: - Children aged 10 years to 18 years who provide written assent and whose parents provide written permission for participation - English-speaking - Subjects in the IBS group will meet Rome III criteria for IBS as determined by a pediatric gastroenterologist. Exclusion Criteria: - Other pain-related diseases, functional gastrointestinal disorders, or somatization disorder - Mental retardation or pervasive developmental disorder or epilepsy - Psychosis - Genetic or chromosomal disorders - Currently receiving psychoactive drug treatment - Patients with pacemakers, metal clips used in previous surgery or other device which are not compatible with MRI scanning - Inability to lie still in the scanner - Claustrophobia (Inability to lie still in the scanner) - Pregnancy - Subjects who admit to substance abuse during screening - Orthodontic braces

Additional Information

Official title Use of Functional Magnetic Resonance Imaging (fMRI) to Study Brain Activation Following Rectal Stimulation in Children With Irritable Bowel Syndrome
Principal investigator Manu Sood, MD
Description Our first aim is to compare the brain areas activated rectal stimulation in boys and girls with IBS and healthy children. Our second aim is to compare the anatomic regions of the brain activated during rectal stimulation in pre and post-pubertal male and female subjects between 10-18 yrs of age.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Medical College of Wisconsin.