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CompletedNCT00677976fMRIUpdated Apr 30, 2020

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

An observational study in Irritable Bowel Syndrome, sponsored by Medical College of Wisconsin. Completed at 1 site in United States. Open to participants aged 10 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-30.

Sponsored by Medical College of Wisconsin · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
17
Ages
10 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Irritable Bowel Syndrome

Keywords

  • fMRI
  • IBS
  • Brain Activation
03

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's enrollment of 17 is below the median of 150 across 178 observational studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.

Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
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.

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
17 participants (actual)

Groups and 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.

06

What researchers measure

Primary outcomes

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

    Time frame: 4 years

07

Study locations

1 site
  • Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
08

References and documents

Publications

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  • Berman S, Munakata J, Naliboff BD, Chang L, Mandelkern M, Silverman D, Kovalik E, Mayer EA. Gender differences in regional brain response to visceral pressure in IBS patients. Eur J Pain. 2000;4(2):157-72. doi: 10.1053/eujp.2000.0167. PubMed 10957697 ↗
  • Naliboff BD, Berman S, Chang L, Derbyshire SW, Suyenobu B, Vogt BA, Mandelkern M, Mayer EA. Sex-related differences in IBS patients: central processing of visceral stimuli. Gastroenterology. 2003 Jun;124(7):1738-47. doi: 10.1016/s0016-5085(03)00400-1. PubMed 12806606 ↗
  • Houghton LA, Lea R, Jackson N, Whorwell PJ. The menstrual cycle affects rectal sensitivity in patients with irritable bowel syndrome but not healthy volunteers. Gut. 2002 Apr;50(4):471-4. doi: 10.1136/gut.50.4.471. PubMed 11889064 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00677976
Lead sponsor
Medical College of Wisconsin
Responsible party
Manu Sood (Chief, Associate Professor, Medical College of Wisconsin) — Principal investigator
First posted
May 15, 2008
Start date
Jun 2007
Primary completion
Jun 2013
Completion
Jun 2013
Last update
Apr 30, 2020

Study contacts

Manu Sood, MD
principal investigator · Medical College of Wisconsin

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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