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Clinical Trials/NCT00677976
NCT00677976
Completed
Not Applicable

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

Medical College of Wisconsin1 site in 1 country17 target enrollmentJune 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Irritable Bowel Syndrome
Sponsor
Medical College of Wisconsin
Enrollment
17
Locations
1
Primary Endpoint
We intend to measure the degree of brain activation following rectal stimulation
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2007
End Date
June 2013
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Manu Sood

Chief, Associate Professor

Medical College of Wisconsin

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

Outcomes

Primary Outcomes

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

Time Frame: 4 years

Study Sites (1)

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