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

NCT00677976 | Completed

• 1 other identifier: CHW 06/163
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

fMRI; IBS; Brain Activation

Outcome Measures

Primary Outcomes (1)

• We intend to measure the degree of brain activation following rectal stimulation

  4 years

Study Arms (2)

IBS

Children between the ages of 10 and 18 who meet Rome III criteria for IBS as determined by a pediatric gastroenterologist.

Control

Healthy children between the ages of 10 and 18.

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children will be selected from the Gastroenterology Clinic at Children's Hospital of Wisconsin.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

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MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Manu Sood, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Associate Professor

Study Record Dates

• First Submitted: May 12, 2008
• First Posted: May 15, 2008
• Study Start: June 1, 2007
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: April 30, 2020

Record last verified: 2020-04

Locations

US (1)