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临床试验/NCT02693730
NCT02693730已完成不适用

Perceptions and Modulations of Visceral Sensations

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
198
试验地点
1
主要终点
Classifying patients with IBS and Ulcerative Colitis (UC) based on their brain "signatures" obtained from structural and functional MRI scanning.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

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

时间窗: 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."

Possible biological mediators of observed IBS related brain network alterations

时间窗: 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.

Global and regional brain network alterations in IBS.

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emeran Mayer, MD

Professor and Director

University of California, Los Angeles

研究点 (1)

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