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

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ClinicalTrials.gov Identifier: NCT00677976
Recruitment Status : Active, not recruiting
First Posted : May 15, 2008
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Manu Sood, 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.

Condition or disease
Irritable Bowel Syndrome

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 Type : Observational
Actual Enrollment : 17 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Use of Functional Magnetic Resonance Imaging (fMRI) to Study Brain Activation Following Rectal Stimulation in Children With Irritable Bowel Syndrome
Study Start Date : June 2007
Actual Primary Completion Date : June 2013
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans
U.S. FDA Resources

Group/Cohort
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.



Primary Outcome Measures :
  1. We intend to measure the degree of brain activation following rectal stimulation [ Time Frame: 4 years ]


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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children will be selected from the Gastroenterology Clinic at Children's Hospital of Wisconsin.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00677976


Locations
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: Manu Sood, MD Medical College of Wisconsin

Publications:

Responsible Party: Manu Sood, Chief, Associate Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00677976     History of Changes
Other Study ID Numbers: CHW 06/163
First Posted: May 15, 2008    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018

Keywords provided by Manu Sood, Medical College of Wisconsin:
fMRI
IBS
Brain Activation

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases