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

NCT ID: NCT00677976

Last Updated: 2020-04-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 17 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2013-06-30

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.

Conditions

Irritable Bowel Syndrome

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

IBS

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

No interventions assigned to this group

Control

Healthy children between the ages of 10 and 18.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Manu Sood

Chief, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manu Sood, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

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Other Identifiers

CHW 06/163

Identifier Type: -

Identifier Source: org_study_id