Brain-Gut Interactions in Crohn's Disease

Completed

• Conditions: Crohn's Disease

• Registration Number: NCT02108938
• Lead Sponsor: University of Wisconsin, Madison

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.

Study Timeline

• Study First Submitted: 2014-03-24
• Study First Submitted QC: 2014-04-04
• Study First Posted: 2014-04-09
• Study Start: 2014-09-10
• Primary Completion: 2015-05-18
• Study Completion: 2015-05-18
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-01
• Last Update Posted: 2019-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) characterize brain changes in patients with CD compared to age and gender-matched controls	1 year	Because of the relatively large number of predictor variables in relation to the potential number of subjects, these analyses will be considered exploratory and aimed at generating hypotheses. Future studies with a larger number of subjects can be focused on hypothesis-driven questions and in developing diagnostic brain-based biomarkers and determining whether novel treatments aimed at the brain-gut axis may alter disease activity and pain perception in this patient population.

Secondary Outcome Measures

Name	Time	Method
2) relate these brain changes to measures of disease activity and pain severity.	1 year	Because of the relatively large number of predictor variables in relation to the potential number of subjects, these analyses will be considered exploratory and aimed at generating hypotheses. Future studies with a larger number of subjects can be focused on hypothesis-driven questions and in developing diagnostic brain-based biomarkers and determining whether novel treatments aimed at the brain-gut axis may alter disease activity and pain perception in this patient population.

Trial Locations

Locations (1)

University of Wisconsin Hospital & Clinics; 🇺🇸 Madison, Wisconsin, United States