Characterizing Brain-Gut Interaction in Patients With Crohn's Disease Using Advanced Neuroimaging Tools
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- 1) characterize brain changes in patients with CD compared to age and gender-matched controls
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
1) characterize brain changes in patients with CD compared to age and gender-matched controls
时间窗: 1 year
Because of the relatively large number of predictor variables in relation to the potential number of subjects, these analyses will be considered exploratory and aimed at generating hypotheses. Future studies with a larger number of subjects can be focused on hypothesis-driven questions and in developing diagnostic brain-based biomarkers and determining whether novel treatments aimed at the brain-gut axis may alter disease activity and pain perception in this patient population.
次要结局
- 2) relate these brain changes to measures of disease activity and pain severity.(1 year)