Brain-Gut Interactions in Crohn's Disease
This trial is active, not recruiting.
|Sponsor||University of Wisconsin, Madison|
|Start date||April 2014|
|End date||May 2015|
|Trial size||20 participants|
|Trial identifier||NCT02108938, 2014-0131|
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.
|Observational model||case control|
1) characterize brain changes in patients with CD compared to age and gender-matched controls
time frame: 1 year
2) relate these brain changes to measures of disease activity and pain severity.
time frame: 1 year
Male or female participants from 18 years up to 90 years old.
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.
|Official title||Characterizing Brain-Gut Interaction in Patients With Crohn's Disease Using Advanced Neuroimaging Tools|
|Principal investigator||Sumona Saha, MD, MS|
|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.|
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