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

Irritable Bowel Syndrome Clinical Trial

— fMRI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00677976
• Other study ID #: CHW 06/163
• Status: Completed
• Start date: June 2007
• Est. completion date: June 2013

Study information

• Verified date: April 2020
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

References & Publications (46)

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* Note: There are 46 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	We intend to measure the degree of brain activation following rectal stimulation		4 years