IBS - Irritable Bowel SyndromeIMAGINENCT03131414
The IMAGINE-SPOR CIHR Chronic Disease Network
An observational study of IBS - Irritable Bowel Syndrome and Ulcerative Colitis, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 4 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- IBS - Irritable Bowel Syndrome, Ulcerative Colitis, Crohn Disease
- What is being tested?
- Diet and Gastrointestinal microbiome
- Type of treatment
- Injection or infusion
- How many people
- 8,000 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2017to 1 Jun 2023
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hamilton Health Sciences / McMaster University
Hamilton, Ontario, L8N 3Z5
Paul Moayyedi, MD, 905-521-2100 ext. 76764, moayyep@mcmaster.ca
Melanie Wolfe, CCRP, 905-521-2100 ext. 73601, wolfe@hhsc.ca
About this study
Official title: Inflammation, Microbiome, and Alimentation: Gastro-Intestinal and Neuropsychiatric Effects: the IMAGINE-CIHR SPOR Chronic Disease Network
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.
Read the 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:
- 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.
- Being tested
- Diet, Gastrointestinal microbiome
- Medical subject headings
- Irritable Bowel Syndrome, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Dietary intake
Gastrointestinal microbiomeOther
Genomic sequencing of stool for gut bacteria
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Diet; Other: Gastrointestinal microbiome | |
| 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. Receives: Other: Diet; Other: Gastrointestinal microbiome | |
| 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. Receives: Other: Diet; Other: Gastrointestinal microbiome | |
| 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. Receives: Other: Diet; Other: Gastrointestinal microbiome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline
Secondary outcomes (5)
IMAGINE metabolomics
Metabolomic comparison between UC, CD, IBS and controls
Measured: baseline and five years
IMAGINE anxiety
Anxiety score evaluated using PROMIS questionnaire between UC, CD, IBS and controls
Measured: baseline and five years
IMAGINE depression
Depression score evaluated using PROMIS questionnaire between UC, CD, IBS and controls
Measured: baseline and five years
IMAGINE health related costs
Health related costs measured by provincial databases and questionnaire between UC, CD, IBS and controls
Measured: baseline and five years
IMAGINE microbiome and diet
Microbiome and dietary comparison between UC, CD, IBS and controls
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start1 Oct 2017
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Paul Moayyedi, Hamilton Health Sciences Corporation
- Investigators
- Paul Moayyedi, MD, Principal investigator, HHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131414
- Sponsor's protocol ID
- REB#3000
- Acronym
- IMAGINE
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2017
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bernstein CN, Nugent Z, Panaccione R, Marshall DA, Kaplan GG, Dieleman LA, Vanner S, Graff LA, Otley A, Jones J, Buresi M, Murthy S, Borgaonkar M, Bressler B, Bitton A, Croitoru K, Sidani S, Fernandes A, Moayyedi P. Symptoms in Persons With Either Active or Inactive Crohn's Disease Are Agnostic to Disease Phenotype: The Magic in Imagine Study. J Clin Gastroenterol. 2026 Jan 1;60(1):61-67. doi: 10.1097/MCG.0000000000002137.
PubMed 39853241Moayyedi P, MacQueen G, Bernstein CN, Vanner S, Bercik P, Madsen KL, Surette M, Rioux JD, Dieleman LA, Verdu E, de Souza RJ, Otley A, Targownik L, Lavis J, Cunningham J, Marshall DA, Zelinsky S, Fernandes A. IMAGINE Network's Mind And Gut Interactions Cohort (MAGIC) Study: a protocol for a prospective observational multicentre cohort study in inflammatory bowel disease and irritable bowel syndrome. BMJ Open. 2020 Oct 21;10(10):e041733. doi: 10.1136/bmjopen-2020-041733.
PubMed 33087380
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation, Microbiome, and Alimentation: Gastro-Intestinal and Neuropsychiatric Effects: the IMAGINE-CIHR SPOR Chronic Disease Network
- ClinicalTrials.gov ID
- NCT03131414
- Acronym / sponsor ID
- IMAGINE / REB#3000
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 27 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Irritable bowel syndrome | – | Other: Diet, Other: Gastrointestinal microbiomeA 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 | – | Other: Diet, Other: Gastrointestinal microbiome2000 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 | – | Other: Diet, Other: Gastrointestinal microbiome2000 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 | – | Other: Diet, Other: Gastrointestinal microbiomeA 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. |
Who may qualify
- Ages
- 4 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- • major gastrointestinal surgery (Roux en y, bowel resection)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietDietary intake | Other | Crohn's disease, Healthy control, Irritable bowel syndrome, Ulcerative colitis |
| Gastrointestinal microbiomeGenomic sequencing of stool for gut bacteria | Other | Crohn's disease, Healthy control, Irritable bowel syndrome, Ulcerative colitis |
Primary outcome
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)
5 secondary outcomes
IMAGINE metabolomics
Time frame: baseline and five years
IMAGINE anxiety
Time frame: baseline and five years
IMAGINE depression
Time frame: baseline and five years
IMAGINE health related costs
Time frame: baseline and five years
IMAGINE microbiome and diet
Time frame: five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Derived from this study: PubMed 39853241Bernstein CN, Nugent Z, Panaccione R, Marshall DA, Kaplan GG, Dieleman LA, Vanner S, Graff LA, Otley A, Jones J, Buresi M, Murthy S, Borgaonkar M, Bressler B, Bitton A, Croitoru K, Sidani S, Fernandes A, Moayyedi P. Symptoms in Persons With Either Active or Inactive Crohn's Disease Are Agnostic to Disease Phenotype: The Magic in Imagine Study. J Clin Gastroenterol. 2026 Jan 1;60(1):61-67. doi: 10.1097/MCG.0000000000002137.
- Derived from this study: PubMed 33087380Moayyedi P, MacQueen G, Bernstein CN, Vanner S, Bercik P, Madsen KL, Surette M, Rioux JD, Dieleman LA, Verdu E, de Souza RJ, Otley A, Targownik L, Lavis J, Cunningham J, Marshall DA, Zelinsky S, Fernandes A. IMAGINE Network's Mind And Gut Interactions Cohort (MAGIC) Study: a protocol for a prospective observational multicentre cohort study in inflammatory bowel disease and irritable bowel syndrome. BMJ Open. 2020 Oct 21;10(10):e041733. doi: 10.1136/bmjopen-2020-041733.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Moayyedi, MD principal investigator
HHSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBS - Irritable Bowel Syndrome and Ulcerative Colitis, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Moayyedi, MD (905-521-2100 ext. 76764, moayyep@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IMAGINE microbiome and diet (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03131414, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.