Brain-Gut Interactions in Crohn's Disease

NCT02108938 | Completed

• 1 other identifier: 2014-0131
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 2) relate these brain changes to measures of disease activity and pain severity.

  1 year

Study Arms (2)

Case

Subject's with Crohn's disease at least 18 years of age

Control

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).

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 18 years of age or older diagnosed with CD, as determined by endoscopy or radiographic imaging, will be targeted for enrollment. Patients with CD in symptomatic remission as defined by a Harvey-Bradshaw score of 3, will be eligible.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital & Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Sumona Saha, MD, MS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: April 9, 2014
• Study Start: September 10, 2014
• Primary Completion: May 18, 2015
• Study Completion: May 18, 2015
• Last Updated: April 3, 2019

Record last verified: 2019-04

Locations

US (1)