Phenotyping IBS: Perceptions and Modulations of Visceral Sensations

NCT02693730 | Completed DMC

• 1 other identifier: 2R01DK048351-15A1
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to improve the understanding of irritable bowel syndrome (IBS) and its underlying cause. The investigators will use magnetic resonance imaging (MRI) to observe differences in the brain between people diagnosed with IBS compared to healthy controls and people with ulcerative colitis, a disease group that has already been characterized. By doing this correlative and comparative study, the investigators hope to gain knowledge on IBS in order to keep the field moving in the right direction and becoming one step closer to discovering effective treatments.

Conditions

Irritable Bowel Syndrome; Ulcerative Colitis; Inflammatory Bowel Disease

Keywords

Irritable Bowel Syndrome; IBS; Ulcerative Colitis; UC; Inflammatory Bowel Disease; IBD; Healthy Control; HC; Visceral Pain; Gut; Neuroimaging; fMRI; resting state; structural MRI; functional MRI; diffusion tensor imaging; MR Spectroscopy

Outcome Measures

Primary Outcomes (3)

• Classifying patients with IBS and Ulcerative Colitis (UC) based on their brain "signatures" obtained from structural and functional MRI scanning.

  Magnetic Resonance Imaging provides investigators with anatomical and functional images of the brain. Analytical neuroimaging tools demonstrate the unique brain properties of subjects in accordance with their conditions, referred to as brain "signatures."

  MRI visit will be 45 min to 1 hour.

• Global and regional brain network alterations in IBS.

  The architecture and wiring of the brain can be characterized using metrics describing the connectedness of brain regions, global and local network communication and signaling, and the contribution of each region to the network's structural integrity and information flow.

  MRI visit will be 45 min to 1 hour.

• Possible biological mediators of observed IBS related brain network alterations

  Proposed plausible pathophysiological mechanisms underlying structural and functional brain changes include: 1) Genetic and epigenetic factors; 2) neuroinflammation; 3) growth factor or stress-mediator induced neuroplastic changes; 4) microbiome derived metabolites.

  There will be a screening visit of about 1 hour with a single blood and stool sample; followed by about 40 minutes of on-line questionnaires.

Study Arms (3)

Healthy Control

Does not have diagnosis of irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD) and is otherwise healthy and able to participate as defined by the exclusionary criteria.

Irritable Bowel Syndrome (IBS)

Diagnosed with IBS and meets the Rome III criteria, in the absence of red flag signs (i.e., unexplained weight loss, bloody stool, fever, anemia)

Ulcerative Colitis (UC)

Clinically and histologically confirmed diagnosis of ulcerative colitis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subject population will be made up of male and female adults between the ages of 18-60 and must fall into one of the following 3 groups: a) irritable bowel syndrome, b) ulcerative colitis, or c) healthy controls. Medical screening will be a physician or a nurse will confirm subject eligibility for the study.Subjects will be recruited from clinics and the community in and around Los Angeles Area.

You may qualify if:

• Meet Rome III criteria for IBS
• No red flag signs (i.e., weight loss, bloody stool, fever, anemia)
• Must have UC diagnosis that is clinically \& histologically confirmed
• If woman of childbearing potential, must be willing to use contraception to avoid pregnancy during the course of the study
• If female, negative urine pregnancy tests at Screening \& MRI Visit
• Willingness to participate in this study as evidenced by signed informed consent form
• ambulatory outpatient (does not depend on wheelchair for mobility)
• English is primary oral and written language

You may not qualify if:

• Major medical intervention occurring in the next 6 months or in the past 6 months
• Presence of significant and ongoing medical problem interfering with participation
• Presence of major psychiatric diagnosis such as schizophrenia, bipolar disorder, PTSD, or Obsessive Compulsive disorder.
• Use of centrally acting medications that will interfere with neuroimaging testing (opiate analgesics, antidepressants).
• Left handed due to importance of laterality in neuroimaging
• Pregnancy or nursing
• Claustrophobia, Ferromagnetic Implants, or other problematic issues preventing subject participation in MRI
• Current or past history of chronic pain syndrome other than IBS in the IBS group
• History of gastrointestinal surgery other than uncomplicated appendectomy or cholecystectomy
• Use of investigational drugs, products, or devices within 28 days prior to screen and through study participation
• use of steroids in the last 6 months

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Oppenheimer Center for Neurobiology of Stress and Resilience

Los Angeles, California, 90095, United States

Location

Related Links

• Oppenheimer family center for Neurobiology of Stress at UCLA website

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples will be collected from both IBS and IBD subjects. A full stool analysis will be performed on the stool of IBS subjects, whereas only calprotectin will be measured in the stool of IBD subjects. Blood will be collected from IBS subjects and HCs.

MeSH Terms

Conditions

Irritable Bowel Syndrome; Colitis, Ulcerative; Inflammatory Bowel Diseases; Visceral Pain

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Colitis; Gastroenteritis; Nociceptive Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emeran Mayer, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: February 29, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)