Healthy Clinical Trial
— IMAGINEOfficial title:
Inflammation, Microbiome, and Alimentation: Gastro-Intestinal and Neuropsychiatric Effects: the IMAGINE-CIHR SPOR Chronic Disease Network
NCT number | NCT03131414 |
Other study ID # | REB#3000 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2017 |
Est. completion date | June 1, 2023 |
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.
Status | Recruiting |
Enrollment | 8000 |
Est. completion date | June 1, 2023 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 99 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - • 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Hamilton Health Sciences / McMaster University | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
Hamilton Health Sciences Corporation | Canadian Institutes of Health Research (CIHR) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | IMAGINE microbiome and diet | 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) | baseline | |
Secondary | IMAGINE metabolomics | Metabolomic comparison between UC, CD, IBS and controls | baseline and five years | |
Secondary | IMAGINE anxiety | Anxiety score evaluated using PROMIS questionnaire between UC, CD, IBS and controls | baseline and five years | |
Secondary | IMAGINE depression | Depression score evaluated using PROMIS questionnaire between UC, CD, IBS and controls | baseline and five years | |
Secondary | IMAGINE health related costs | Health related costs measured by provincial databases and questionnaire between UC, CD, IBS and controls | baseline and five years | |
Secondary | IMAGINE microbiome and diet | Microbiome and dietary comparison between UC, CD, IBS and controls | five years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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