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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00677976
First Posted: May 15, 2008
Last Update Posted: February 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Manu Sood, Medical College of Wisconsin
  Purpose
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
Irritable Bowel Syndrome

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Manu Sood, Medical College of Wisconsin:

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

Enrollment: 17
Study Start Date: June 2007
Estimated Study Completion Date: December 2017
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility

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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
  Contacts and Locations
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
  More Information

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 Submitted: May 12, 2008
First Posted: May 15, 2008
Last Update Posted: February 13, 2017
Last Verified: February 2017

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