Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 355 for:    IMAGINE | Recruiting Studies
Previous Study | Return to List | Next Study

The IMAGINE-SPOR CIHR Chronic Disease Network (IMAGINE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03131414
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : March 7, 2019
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Paul Moayyedi, Hamilton Health Sciences Corporation

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.

Condition or disease Intervention/treatment
IBS - Irritable Bowel Syndrome Ulcerative Colitis Crohn Disease Healthy Other: Diet Other: Gastrointestinal microbiome

Detailed 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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 8000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Inflammation, Microbiome, and Alimentation: Gastro-Intestinal and Neuropsychiatric Effects: the IMAGINE-CIHR SPOR Chronic Disease Network
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.

Other: Diet
Dietary intake

Other: Gastrointestinal microbiome
Genomic sequencing of stool for gut bacteria

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.

Other: Diet
Dietary intake

Other: Gastrointestinal microbiome
Genomic sequencing of stool for gut bacteria

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.

Other: Diet
Dietary intake

Other: Gastrointestinal microbiome
Genomic sequencing of stool for gut bacteria

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.

Other: Diet
Dietary intake

Other: Gastrointestinal microbiome
Genomic sequencing of stool for gut bacteria




Primary Outcome Measures :
  1. IMAGINE microbiome and diet [ Time Frame: 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)


Secondary Outcome Measures :
  1. IMAGINE metabolomics [ Time Frame: baseline and five years ]
    Metabolomic comparison between UC, CD, IBS and controls

  2. IMAGINE anxiety [ Time Frame: baseline and five years ]
    Anxiety score evaluated using PROMIS questionnaire between UC, CD, IBS and controls

  3. IMAGINE depression [ Time Frame: baseline and five years ]
    Depression score evaluated using PROMIS questionnaire between UC, CD, IBS and controls

  4. IMAGINE health related costs [ Time Frame: baseline and five years ]
    Health related costs measured by provincial databases and questionnaire between UC, CD, IBS and controls

  5. IMAGINE microbiome and diet [ Time Frame: five years ]
    Microbiome and dietary comparison between UC, CD, IBS and controls


Biospecimen Retention:   Samples With DNA
Whole blood, serum, urine and stool


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
There will be 17 recruitment centres across Canada responsible for recruitment of 2000 subjects with CD, 2000 subjects with UC, 2000 subjects with IBS and 2000 healthy controls. Each centre will be required to obtain appropriate ethics approval prior to initiating study recruitment.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131414


Contacts
Layout table for location contacts
Contact: Paul Moayyedi, MD 905-521-2100 ext 76764 moayyep@mcmaster.ca
Contact: Melanie AM Wolfe, CCRP 905-521-2100 ext 73601 wolfe@hhsc.ca

Locations
Layout table for location information
Canada, Ontario
Hamilton Health Sciences / McMaster University Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Paul Moayyedi, MD    905-521-2100 ext 76764    moayyep@mcmaster.ca   
Contact: Melanie Wolfe, CCRP    905-521-2100 ext 73601    wolfe@hhsc.ca   
Principal Investigator: Paul Moayyedi, MD         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Canadian Institutes of Health Research (CIHR)
Investigators
Layout table for investigator information
Principal Investigator: Paul Moayyedi, MD HHSC
Additional Information:

Layout table for additonal information
Responsible Party: Paul Moayyedi, Principal Investigator, Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT03131414    
Other Study ID Numbers: REB#3000
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Colitis, Ulcerative
Irritable Bowel Syndrome
Chronic Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases
Colonic Diseases, Functional
Disease Attributes
Pathologic Processes