Clinical trial NCT02108938: Brain-Gut Interactions in Crohn's Disease
Official title: Characterizing Brain-Gut Interaction in Patients With Crohn's Disease Using Advanced Neuroimaging Tools
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2014-04-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18 years of age or older diagnosed with CD, as determined by endoscopy or radiographic imaging, will be targeted for enrollment. Patients with CD in symptomatic remission as defined by a Harvey-Bradshaw score of 3, will be eligible.

Brief summary: The primary aims for this research are to 1) characterize brain changes in patients with CD compared to age and gender-matched controls and 2) relate these brain changes to measures of disease activity and pain severity.

Detailed description: Brain-gut interactions have been studied in chronic pain conditions of the gastrointestinal (GI) tract such as irritable bowel syndrome (IBS) and chronic pancreatitis. These studies suggest that alterations in the brain-gut axis may relate to disease severity and pain perception. Inflammatory bowel disease (IBD) is a chronic inflammatory disorder characterized by periods of disease activity and periods of disease quiescence. Crohn's disease (CD) is one of the two major subtypes of IBD. Patients with CD typically experience abdominal pain when the disease is active; however, many also report experiencing pain in the absence of objective evidence of inflammation. Alterations in brain-gut interactions may explain the perception of pain in these patients. Currently, there is a paucity of data regarding brain changes in patients with IBD and CD, specifically. We are proposing a pilot study to characterize brain-gut interactions of disease activity and pain modulation mechanisms in patients with IBD using advanced neuroimaging tools.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* A diagnosis of Crohn's disease by endoscopy or radiographic imaging
* Must have Crohn's disease in symptomatic remission as defined by a Harvey-Bradshaw score of 3
* No contraindications to MRI per UWHC screening form
* Able to provide informed consent

Exclusion Criteria:

* Women that are pregnant
* Contraindications to MRI per UWHC screening form
* Other chronic pain disorders (e.g. fibromyalgia, rheumatoid arthritis, irritable bowel disorder) unrelated to their diagnosis of IBD.
* Scheduled medications for the treatment of pain (e.g. acetaminophen, non-steroidal anti-inflammatory drugs, narcotics) will be excluded.

Primary outcomes:
measure: 1) characterize brain changes in patients with CD compared to age and gender-matched controls
timeFrame: 1 year
Secondary outcomes:
measure: 2) relate these brain changes to measures of disease activity and pain severity.
timeFrame: 1 year
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital & Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Sumona Saha, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: