Brain-Gut Interactions in Crohn's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-10

Study Completion Date

2015-05-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Can CT Enteroclysis Predict the Outcome of Crohn's Disease

NCT00572780

Crohn's Disease

COMPLETED

Pain in Patients With Crohn Disease (PAINCD)

NCT04488146

Crohn Disease Pain Depression, Anxiety

UNKNOWN

Value of PET/MR Enterography in the Assessment of Crohn's Disease Using a Collagen-binding Radiotracer.

NCT06252493

Crohn Disease

RECRUITING

Neurophenotype Predicts CD Disease Progression

NCT06452550

Radiomics Multi-omics

RECRUITING

Microbial Community Characteristics in Intestinal Mucosal Tissue of Patients With CD

NCT06895772

Crohn's Disease (CD)

ACTIVE_NOT_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Crohn's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Case

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

No interventions assigned to this group

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).

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No