Naturalistic Monitoring of Microglial Activation in Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- change in TSPO VT in prefrontal cortex, anterior cingulate cortex, and insula before and after 3 to 6 months
研究概览
简要总结
The purpose of this study is to monitor microglial activation in participants with inflammatory bowel disease (IBD) and investigate the relationship that exists between these patients and their risk of acquiring major depressive episodes (MDE). Patients with both IBD and MDE will be subsequently approached to participate in the study.
详细描述
Detailed Description:
Participants may undergo up to 3 PET Scans : [18F]FEPPA PET (for TSPO) before and 3 to 6 months later and [11C]SL25.1188 PET (for MAO-B) as well as 1 MRI scan.
The primary hypothesis is that :
- The neuroinflammation (TSPO VT) will be increased in PFC, ACC, and insula regions in those with inflammatory bowel disease (IBD) patients compared to healthy people.
- The neuroinflammation (TSPO VT) in PFC, ACC, and insula regions will be reduced after treatment for IBD.
The Secondary Hypothesis:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 65
- •aside from IBD groups and common comorbidities of IBD, otherwise good physical health with no current active medical conditions.
- •a lifetime diagnosis of IBD verified by medical record, which can include prescription for IBD treatment
排除标准
- •no history of neurological illness, excluding migraine
- •no use of glucocorticoid antagonists or lithium or medications that bind with affinity higher than 500nM to peripheral benzodiazepine receptors (or TSPO) in the previous two months
- •no use of herbal remedies in the previous month that would be expected to influence neuroinflammation
- •non-cigarette smoking
- •no history of abuse of substances that affect mood and negative urine drug screens for substances of abuse including cotinine (urine drug screen is done at screening and on each PET scan day)
- •no history of psychotic symptoms
- •not pregnant based on a negative pregnancy test (for women)
- •not breastfeeding (for women)
- •no recent treatment with electroconvulsive therapy or magnetic seizure therapy in the previous 6 months
- •no coagulation disorders, or anticoagulant medication use
- •no presence of metal objects or implanted electrical devices in the body that would preclude MRI scanning
- •no claustrophobia
- •no self-reported history of fainting from blood withdrawals
- •size and weight does not exceed capacity of scanner, for which size may vary and weight is 350 lbs
- •no history of undergoing a number of PET scans that, including the number of PET scans under this protocol, will bring the total to more than 8 PET scans/lifetime, exceeding permissible limit for subjects participating in research set by our centre's guidelines
结局指标
主要结局
change in TSPO VT in prefrontal cortex, anterior cingulate cortex, and insula before and after 3 to 6 months
时间窗: 3 to 6 months
Change in TSPO VT for three regions (same units for each region)
TSPO VT in prefrontal cortex, anterior cingulate cortex, and insula
时间窗: within 3 to 4 weeks after initiation of screening
Between group comparison for 3 regions in IBD compared to controls (analysis done concurrently for group effect across 3 regions)
MAO-B VT in prefrontal cortex, anterior cingulate cortex, insula in IBD compared to controls
时间窗: within 3 to 4 weeks after initiation of screening
Between group comparison for 3 regions in IBD compared to controls
次要结局
- change in TSPO VT in prefrontal cortex, anterior cingulate cortex, insula compared between naturalistic treatment with sulfasalazine/5-aminosalicylates versus other interventions like biologics or fecal transplantation(3 to 6 months)
- TSPO VT in prefrontal cortex, anterior cingulate cortex, insula compared between Crohns disease and ulcerative colitis(within 3 to 4 weeks of initiating screening of subjects)
- TSPO VT in prefrontal cortex, anterior cingulate cortex, insula compared between IBD with MDE compared to MDE controls(within 3 to 4 weeks after initiation of screening)
研究者
Jeff Meyer
Program Head, Neurochemical Imaging for Mood Disorders
Centre for Addiction and Mental Health