Overview

This trial is active, not recruiting.

Condition crohn's disease
Sponsor University of Wisconsin, Madison
Start date April 2014
End date May 2015
Trial size 20 participants
Trial identifier NCT02108938, 2014-0131

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Subject's with Crohn's disease at least 18 years of age
Findings from this study will be compared to "controls." These controls will come from the well documented CNS changes which have been found in patients with IBS and chronic pancreatitis (HS-IRB# 2013-1561 and HS-IRB 2009-0171).

Primary Outcomes

Measure
1) characterize brain changes in patients with CD compared to age and gender-matched controls
time frame: 1 year

Secondary Outcomes

Measure
2) relate these brain changes to measures of disease activity and pain severity.
time frame: 1 year

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.