Use of Functional Magnetic Resonance Imaging (fMRI) to Study Brain Activation in Children With Irritable Bowel Syndrome

Completed

• Conditions: Irritable Bowel Syndrome

• Registration Number: NCT00677976
• Lead Sponsor: Medical College of Wisconsin

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-05-12
• Study First Submitted QC: 2008-05-12
• Study First Posted: 2008-05-15
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-29
• Last Update Posted: 2020-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
We intend to measure the degree of brain activation following rectal stimulation	4 years

Trial Locations

Locations (1)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States