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Completed

NCT Number: NCT00677976

Use of Functional Magnetic Resonance Imaging (fMRI) to Study Brain Activation 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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

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

Acronym: fMRI

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
May 15, 2008
Registry last updated
Apr 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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