Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. Subjects with a confirmed diagnosis of IBS or IBD and who have given prior consent to be contacted, will be prescreened by phone or in person. All others will be invited to a screening visit and the study rationale and design will be explained. Interested subjects will be asked to provide informed written consent. Eligibility will then be confirmed and subjects will complete the questionnaires and provide the necessary samples at this and a follow-up visit if necessary. Subjects who do not meet the diagnostic criteria for IBS or IBD and wish to have the diagnosis confirmed, will be advised to see their family physician for any necessary diagnostic testing. A letter to the family physician will be provided stating that the patient had been approached about the study and that the diagnosis of IBS/IBD could not been made due to an absence of testing and/or failure to meet the predefined criteria. Patients will also be informed if they fail to meet other eligibility criteria that would exclude them from the study. When eligibility for subjects and healthy controls has been confirmed, the following questionnaires will be answered and samples obtained: - Blood samples - Metabolomic urine sample - Stool sample (metagenomics, metabolomics, fecal calprotectin (FCAL) and β-defensins) - Demographic questionnaire - Quality of life questionnaire (EQ-5D for adults) - Food Frequency Questionnaire - Psychological questionnaires (pediatric for ≤ 17 years, adult for those > 17 years) - Optional on-line additional psychological questionnaires for adults - Disease specific questionnaires (UC, CD and IBS - UC and CD further divided into pediatric for ≤ 17 years, adult for those > 17 years) - General gastrointestinal symptom questionnaires (Short for Leeds Dyspepsia Questionnaire, PROMIS diarrhea, PROMIS abdominal pain, PROMIS constipation and PROMIS bloating). - Workplace productivity questionnaire. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03131414
Study type Observational [Patient Registry]
Source Hamilton Health Sciences Corporation
Contact Paul Moayyedi, MD
Phone 905-521-2100
Email moayyep@mcmaster.ca
Status Recruiting
Phase
Start date October 1, 2017
Completion date June 1, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1