Clinical trial NCT00677976: Use of Functional Magnetic Resonance Imaging (fMRI) to Study Brain Activation in Children With Irritable Bowel Syndrome
Official title: Use of Functional Magnetic Resonance Imaging (fMRI) to Study Brain Activation Following Rectal Stimulation in Children With Irritable Bowel Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irritable Bowel Syndrome
Keywords: fMRI
IBS
Brain Activation
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2008-05-15
Enrollment: 17
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children will be selected from the Gastroenterology Clinic at Children's Hospital 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.

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 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

Primary outcomes:
measure: We intend to measure the degree of brain activation following rectal stimulation
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Manu Sood, MD
role: PRINCIPAL_INVESTIGATOR
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