ClinicalTrials.Veeva

Menu

Brain-Gut Interactions in Crohn's Disease

University of Wisconsin (UW) logo

University of Wisconsin (UW)

Status

Completed

Conditions

Crohn's Disease

Study type

Observational

Funder types

Other

Identifiers

NCT02108938
2014-0131

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

25 participants in 2 patient groups

Case
Description:
Subject's with Crohn's disease at least 18 years of age
Control
Description:
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).

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems