Inflammation, Microbiome, and Alimentation: Gastro-Intestinal and Neuropsychiatric Effects: the IMAGINE-CIHR SPOR Chronic Disease Network
试验速览
- 阶段
- 不适用
- 入组人数
- 8,000
- 试验地点
- 1
- 主要终点
- IMAGINE microbiome and diet
研究概览
简要总结
The IMAGINE Cohort Study will identify and recruit a cohort of 8000 patients with IBS, IBD and healthy controls (2000 of each) who will be assessed in terms of their psychological status, dietary intake, gut microbiome, metabolomic and inflammatory markers and genotype, health-related quality of life, and health care resource use and associated costs. The cohort and healthy controls will be followed prospectively for up to 5 years after the completion of study enrolment.
详细描述
The goal of the screening visit is to confirm that the Subject/Healthy Control is willing to participate in the study and that they meet the eligibility criteria for the study.
The screening visit will include:
i. Obtaining signed informed consent /assent to screen for eligibility (Consent/Assent-Subject, Consent/Assent-Control).
ii. Reviewing the subject/control for eligibility (per inclusion/exclusion criteria).
Subjects will be identified through several pathways: 1) Patients with confirmed IBS or IBD in existing site databases who have previously consented to be contacted for future IBS studies or those approached in clinic with a recent confirmed diagnosis of IBS/IBD and consent to participate and 2) patients with self-reported IBS or IBD who contact the site coordinator or who are identified in clinic with an unsubstantiated diagnosis of IBS/IBD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Each control that agrees to participate will undergo an initial screening questionnaire to confirm that they are healthy and have no gastrointestinal symptoms using the ROME IV Questionnaire.
排除标准
- •• major gastrointestinal surgery (Roux en y, bowel resection)
- •any major comorbid chronic condition (e.g. decompensated liver disease or malignancy, lung or cardiac disease, active HIV, diabetes mellitus requiring medication,
- •difficulties with communication or conditions affecting ability to provide informed consent,
- •unable to communicate in the language of the cohort study (English or French)
- •those who do not wish to participate in this study
- •diagnosis of schizophrenia
- •diagnosis of eating disorder
结局指标
主要结局
IMAGINE microbiome and diet
时间窗: baseline
Microbiome and dietary comparison between UC, CD, IBS and controls predictors of failure of therapy (each class of therapy in UC, CD, IBS and each disease will be analyzed separately)
次要结局
- IMAGINE metabolomics(baseline and five years)
- IMAGINE anxiety(baseline and five years)
- IMAGINE health related costs(baseline and five years)
- IMAGINE microbiome and diet(five years)
- IMAGINE depression(baseline and five years)
研究者
Paul Moayyedi
Principal Investigator
Hamilton Health Sciences Corporation