Skip to content

Brain-Gut Interactions in Crohn's Disease

Characterizing Brain-Gut Interaction in Patients With Crohn's Disease Using Advanced Neuroimaging Tools

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02108938
Enrollment
25
Registered
2014-04-09
Start date
2014-09-10
Completion date
2015-05-18
Last updated
2019-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

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.

Interventions

None listed

Sponsors

University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
1) characterize brain changes in patients with CD compared to age and gender-matched controls1 yearBecause 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

MeasureTime frameDescription
2) relate these brain changes to measures of disease activity and pain severity.1 yearBecause 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026