Recruiting

Observational Study

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT03131414

Conditions

IBS - Irritable Bowel Syndrome

Ulcerative Colitis

Crohn Disease

Healthy

Eligibility Criteria

Sex: All

Age: 4 - 70+

Healthy Volunteers: Accepted

Interventions

Diet

Gastrointestinal microbiome

Study Details

Brief 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.

Conditions

IBS - Irritable Bowel Syndrome

Ulcerative Colitis

Crohn Disease

Healthy

Study ID

NCT03131414

Start date

Oct 1, 2017

Status verified date

Mar, 2022

Completion date

Jun 1, 2023

Anticipated

Primary completion date

Dec 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

8000 participants

Anticipated

Interventions and Outcome Measures

Arms

Irritable bowel syndrome

A total of 2000 patients with IBS who have met Rome IV criteria are 13 years of age or older will be consented and recruited for this study.

IBS patients will be categorized into diarrhea predominant IBS (IBS-D), constipation predominant IBS (IBS-C) or alternating constipation and diarrhea (IBS-A) or unclassified IBS (IBS-U). A detailed diet history will be obtained and gastrointestinal microbiome will be evaluated.

Ulcerative colitis

2000 CD and 2000 UC cases over the age of 4 years will be enrolled.

Montreal Classification will be used for adult UC patients, and the Paris classification for pediatric UC. The research coordinator will conduct a chart review to confirm date of diagnosis and maximal phenotype at time of enrolment. A detailed diet history will be obtained and gastrointestinal microbiome will be evaluated.

Crohn's disease

2000 CD cases over the age of 4 years will be enrolled.

Montreal Classification will be used for adult CD patients, and the Paris classification for pediatric CD. The research coordinator will conduct a chart review to confirm date of diagnosis and maximal phenotype at time of enrolment. A detailed diet history will be obtained and gastrointestinal microbiome will be evaluated.

Healthy control

A total of 2000 healthy family members, relative or friends of cohort participants over the age of 4 will be consented and recruited for this study.

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. A detailed diet history will be obtained and gastrointestinal microbiome will be evaluated.

Interventions

Diet

Dietary intake

Gastrointestinal microbiome

Genomic sequencing of stool for gut bacteria

Primary outcome measure

  • IMAGINE microbiome and diet [ Time Frame: baseline ]

Central Contacts and Locations

Central contacts

Paul Moayyedi, MD

905-521-2100moayyep@mcmaster.ca

Melanie AM Wolfe, CCRP

905-521-2100wolfe@hhsc.ca

Locations

Hamilton Health Sciences / McMaster University

Recruiting

Hamilton, Ontario, Canada, L8N 3Z5

Contacts

Paul Moayyedi, MD

905-521-2100moayyep@mcmaster.ca

Melanie Wolfe, CCRP

905-521-2100wolfe@hhsc.ca

Principal Investigator:

Paul Moayyedi, MD

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Mar 16, 2022

Last verified

Mar, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2022-03-16.