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

April 29, 2020 updated by: Manu Sood, Medical College of Wisconsin

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

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.

Study Overview

Status

Completed

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

Enrollment (Actual)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
We intend to measure the degree of brain activation following rectal stimulation
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

May 12, 2008

First Submitted That Met QC Criteria

May 12, 2008

First Posted (ESTIMATE)

May 15, 2008

Study Record Updates

Last Update Posted (ACTUAL)

April 30, 2020

Last Update Submitted That Met QC Criteria

April 29, 2020

Last Verified

April 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Irritable Bowel Syndrome

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