Phenotyping IBS: Perceptions and Modulations of Visceral Sensations
Condition: Irritable Bowel Syndrome; Ulcerative Colitis; Inflammatory Bowel Disease
MeSH terms: Colitis; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases; Irritable Bowel Syndrome
Study type: Observational

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.
    

Detailed description: 
      Despite recent breakthroughs in research, irritable bowel syndrome (IBS) lacks a
      comprehensive mechanistic characterization. While the symptoms of this gastroenterological
      disorder have been described, the overall assessment of IBS has not led to sufficient
      treatment and management plans. By moving away from an over-reliance on a symptom-based
      approach and shifting towards a mechanism-based approach, investigators will be more
      knowledgeable as they attempt to address the disease. In order to accomplish this, the
      investigators will work with different patient subgroups, specifically IBS subjects, healthy
      controls (HCs), and disease control groups such as ulcerative colitis (UC). This will allow
      for the comparison of significant genetic, social, biological, and neurological findings
      between subgroups, which will help investigators grasp the differences present in people who
      suffer from IBS.

      The investigators will approach the study in a couple different ways to characterize IBS in
      the best possible manner. Blood samples and MRI brain images will be collected so that the
      genetic and neurological factors associated with IBS can be explored. Given the highly
      interactive nature of the biological systems within the body, the investigators plan to
      explore the interaction between the brain and the immune system as well as the brain and the
      gut. In doing so, specific genes that contribute to IBS, as well as changes in the brain that
      contribute to or result from IBS, can be further scrutinized.Additionally, the immune
      system's influence on the brain in IBS patients can be compared to healthy controls or UC.
      All of this information will contribute to therapeutic studies in the future as investigators
      continue to develop both diagnostic tools and treatments for IBS patients.

      Conducting this study necessitates the use of human subjects for research purposes. In total,
      the investigators will recruit 120 IBS subjects, 70 age-matched HCs, and 100 UC subjects.
      During the initial screening visit, the subject will complete a physical examination, a short
      psychological evaluation (MINI+), a pressure & heat sensitivity test, a quick blood draw, and
      a set of questionnaires. In total, this baseline visit will take roughly two hours.

      On the second visit, the subject will return to complete more questionnaires and have their
      brains scanned by an MRI machine. The subject will then be disclosed of MRI safety procedures
      and once they are cleared, they will undergo a 60 minute scanning session with a certified
      MRI technician. Once this has been complete, the subject will have completed the study.

      IBS female subjects that have indicated they would like to be part of the longitudinal study
      will return at 3 months, 6 months, 9 months, and 12 months for the same MRI procedure
      described above, with MR-Spectroscopy being an additional modality. They will also complete a
      5 minute online survey every month for 9 months to assess their symptoms.

      The Neuroimaging Core at the Center for Neurobiology of Stress will be responsible for all
      brain imaging analyses in years 4-5. Gene expression profiling assays and all microbiome
      related studies will occur at the Neuroscience Genomics Core Laboratory and the UCLA Center
      for Systems Biomedicine in years 4-5 as well.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
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.
      
Biospecimen description: 
      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.
    
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