Brain-Gut Interactions in Crohn's Disease

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02108938
• Other study ID #: 2014-0131
• Status: Completed
• Start date: September 10, 2014
• Est. completion date: May 18, 2015

Study information

• Verified date: April 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 18, 2015
• Est. primary completion date: May 18, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital & Clinics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1) characterize brain changes in patients with CD compared to age and gender-matched controls	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.	1 year
Secondary	2) relate these brain changes to measures of disease activity and pain severity.	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.	1 year