Phenotyping IBS: Perceptions and Modulations of Visceral Sensations (PMVS-P)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02693730|
Recruitment Status : Recruiting
First Posted : February 29, 2016
Last Update Posted : October 16, 2018
|Condition or disease|
|Irritable Bowel Syndrome Ulcerative Colitis Inflammatory Bowel Disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||290 participants|
|Official Title:||Perceptions and Modulations of Visceral Sensations|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||December 2020|
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
- Classifying patients with IBS and Ulcerative Colitis (UC) based on their brain "signatures" obtained from structural and functional MRI scanning. [ Time Frame: MRI visit will be 45 min to 1 hour. ]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."
- Global and regional brain network alterations in IBS. [ Time Frame: MRI visit will be 45 min to 1 hour. ]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.
- Possible biological mediators of observed IBS related brain network alterations [ Time Frame: 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. ]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.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02693730
|Contact: Kimberly Gonzalez, BSemail@example.com|
|Contact: Jean Stains, RNfirstname.lastname@example.org|
|United States, California|
|Oppenheimer Center for Neurobiology of Stress and Resilience||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Kimberly Gonzalez, BS 310-825-7217 email@example.com|
|Contact: Jean Stains, RN 310-206-1758 firstname.lastname@example.org|
|Principal Investigator: Emeran Mayer, MD|
|Principal Investigator:||Emeran Mayer, MD||University of California, Los Angeles|