Inflammatory Bowel DiseaseNCT02152241
Long-term Functional Outcome of Children With Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Disease, run by University of Manitoba at 1 site in Canada.
Trial summary
Inflammatory bowel diseases (IBD) are group of immune system disorders characterized by a chronic course with remission and relapses. Canada is one of the countries with the highest prevalence and incidence rates of IBD with 25% of patients present in children and adolescents. Read more about this study
- Who is it for?
- Ages 24 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease
- How many people
- 105 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2014to Jun 2016
- 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 24 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The participant population will be comprised of adult patients who were initially diagnosed with IBD in childhood or adolescence (diagnosis was made < age of 18 years) and who were followed by the Section of Pediatric Gastroenterology at the Winnipeg Children's Hospital from 1974 - 2009. Controls: age and sex-matched control group will be generated using the Canadian Community Health Survey (CCHS) 2012 (16) with access through the local Research and Data Centre (RDC).
Who may be able to join
- adult patients who were initially diagnosed with IBD in childhood or adolescence (diagnosis was made < age of 18 years) and who were followed by the Section of Pediatric Gastroenterology at the Winnipeg Children's Hospital from 1974 - 2009.
Who cannot join
- Patients in whom the diagnosis of IBD was not fully established following the current North American Society of Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) guidelines for diagnosing IBD i.e. had clinical, radiologic and endoscopic evidence of IBD (2).
- Control participants with other chronic debilitating diseases (e.g. malignancy, rheumatoid arthritis, multiple sclerosis, etc..) that may affect quality of life and functional outcome
Trial locations and contacts
1 site in 1 country.
About this study
Inflammatory bowel diseases (IBD) are group of immune system disorders characterized by a chronic course with remission and relapses. Canada is one of the countries with the highest prevalence and incidence rates of IBD with 25% of patients present in children and adolescents.
As with any chronic illness, IBD diagnosed early in life has a significant impact on the physical, emotional and social development of those affected. Consequently, it is logical to speculate that patients with IBD may not do as well in education levels or employment status attained compared to their peers without IBD. If this were the case, then interventions could begin in childhood to better prepare patients with IBD for the challenges of living with a chronic disease. Alternatively, if it is shown that they reach comparable social or employment milestones as adults compared to unaffected peers then this would be enormously reassuring to children and their parents.
Read more
Properly designed studies to help in defining more appropriate interventions to these patients are needed.
The proposed study includes circulating a survey to evaluate the functioning level of adult patients with IBD who were diagnosed during their childhood. The participants will be asked a series of questions regarding their highest level of educational achievement, the nature of their current employment, and their current marital status. The question format will parallel that of the Canadian Community Health Survey from which data from an age matched healthy adult Manitobans will be extracted and used as another control group. Responses will be analysed for any possible differences between these groups.
- Conditions
- Inflammatory Bowel Disease
- Keywords
- IBD, Crohn, Colitis, Function
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with IBD | Adult patients with IBD diagnosed during childhood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome (highest level of education attained and current occupation) of those with IBD compared to age and sex-matched healthy adult Manitobans
The highest level of education attained and current occupation will be obtained from participants using structured questionnaire (non-validated interview questionnaire) e.g.
Employed: Y N If No, Unemployed Y N, Disabled Y N , Homemaker Y N Student Y N, Retired Y N Is the cause of not working disease-related Y N
Measured: 12 months
Secondary outcomes (1)
Functional outcome of patients with Crohn's disease (CD) versus those with ulcerative colitis (UC)
The same structured questionnaire tool will be used. Data will be collected on the highest level of education achieved and the current occupation including any periods of unemployment and if this is disease-related or not
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wael El-Matary, MD, Principal investigator, Associate Professor, Univeristy of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152241
- Sponsor's protocol ID
- H2014:155
- Status last verified
- Oct 2016
- First submitted
- 26 May 2014
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
El-Matary W, Dufault B, Moroz SP, Schellenberg J, Bernstein CN. Education, Employment, Income, and Marital Status Among Adults Diagnosed With Inflammatory Bowel Diseases During Childhood or Adolescence. Clin Gastroenterol Hepatol. 2017 Apr;15(4):518-524. doi: 10.1016/j.cgh.2016.09.146. Epub 2016 Oct 4.
PubMed 27717842
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Functional Outcome of Children With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT02152241
- Acronym / sponsor ID
- H2014:155
- Conditions
- Inflammatory Bowel Disease
- Keywords
- IBD, Crohn, Colitis, Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 2 Jun 2014 (estimated)
- 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.
Inflammatory bowel diseases (IBD) are group of immune system disorders characterized by a chronic course with remission and relapses. Canada is one of the countries with the highest prevalence and incidence rates of IBD with 25% of patients present in children and adolescents.
As with any chronic illness, IBD diagnosed early in life has a significant impact on the physical, emotional and social development of those affected. Consequently, it is logical to speculate that patients with IBD may not do as well in education levels or employment status attained compared to their peers without IBD. If this were the case, then interventions could begin in childhood to better prepare patients with IBD for the challenges of living with a chronic disease. Alternatively, if it is shown that they reach comparable social or employment milestones as adults compared to unaffected peers then this would be enormously reassuring to children and their parents.
Properly designed studies to help in defining more appropriate interventions to these patients are needed.
The proposed study includes circulating a survey to evaluate the functioning level of adult patients with IBD who were diagnosed during their childhood. The participants will be asked a series of questions regarding their highest level of educational achievement, the nature of their current employment, and their current marital status. The question format will parallel that of the Canadian Community Health Survey from which data from an age matched healthy adult Manitobans will be extracted and used as another control group. Responses will be analysed for any possible differences between these groups.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with IBD | – | –Adult patients with IBD diagnosed during childhood |
Who may qualify
- Ages
- 24 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The participant population will be comprised of adult patients who were initially diagnosed with IBD in childhood or adolescence (diagnosis was made < age of 18 years) and who were followed by the Section of Pediatric Gastroenterology at the Winnipeg Children's Hospital from 1974 - 2009. Controls: age and sex-matched control group will be generated using the Canadian Community Health Survey (CCHS) 2012 (16) with access through the local Research and Data Centre (RDC).
Key inclusion criteria (1 listed)
- adult patients who were initially diagnosed with IBD in childhood or adolescence (diagnosis was made < age of 18 years) and who were followed by the Section of Pediatric Gastroenterology at the Winnipeg Children's Hospital from 1974 - 2009.
Key exclusion criteria (2 listed)
- Patients in whom the diagnosis of IBD was not fully established following the current North American Society of Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) guidelines for diagnosing IBD i.e. had clinical, radiologic and endoscopic evidence of IBD (2).
- Control participants with other chronic debilitating diseases (e.g. malignancy, rheumatoid arthritis, multiple sclerosis, etc..) that may affect quality of life and functional outcome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional outcome (highest level of education attained and current occupation) of those with IBD compared to age and sex-matched healthy adult Manitobans
Time frame: 12 months
The highest level of education attained and current occupation will be obtained from participants using structured questionnaire (non-validated interview questionnaire) e.g. Employed: Y N If No, Unemployed Y N, Disabled Y N , Homemaker Y N Student Y N, Retired Y N Is the cause of not working disease-related Y N
1 secondary outcome
Functional outcome of patients with Crohn's disease (CD) versus those with ulcerative colitis (UC)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Derived from this study: PubMed 27717842El-Matary W, Dufault B, Moroz SP, Schellenberg J, Bernstein CN. Education, Employment, Income, and Marital Status Among Adults Diagnosed With Inflammatory Bowel Diseases During Childhood or Adolescence. Clin Gastroenterol Hepatol. 2017 Apr;15(4):518-524. doi: 10.1016/j.cgh.2016.09.146. Epub 2016 Oct 4.
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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.
Wael El-Matary, MD principal investigator
Associate Professor, Univeristy of Manitoba
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 Inflammatory Bowel Disease, run by University of Manitoba 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 2 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: finished, as of the sponsor's last update on 26 Oct 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome (highest level of education attained and current occupation) of those with IBD compared to age and sex-matched healthy adult Manitobans (time frame: 12 months). 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 NCT02152241, which also lists 1 linked publication.
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 26 Oct 2016.