Crohn DiseasePROMICINCT04887428
Occupational Insertion and Educational Level of Adult Patients With Pediatric Early Inflammatory Bowel Disease (IBD)
An observational study of Crohn Disease and Ulcerative Colitis, run by University Hospital, Lille at 1 site in France.
Trial summary
The main objective of this project is to assess the occupational insertion of these adult patients with pediatric-onset IBD and to compare it with the general population. The secondary objectives are: 1. to assess the level of education and compare it to that of the general population 2. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Crohn Disease, Ulcerative Colitis
- How many people
- 343 participants
- Where
- 1 siteFrance
- Study dates
- 28 Nov 2019to 28 Jan 2023
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pediatric-onset IBD (diagnosed before the age of 17) and aged over 25 at the time of the study.
Who may be able to join
- Male or female, aged 25 and over at the time of the study
- Subject listed in the EPIMAD registry suffering from certain or probable Crohn's disease, or certain or probable ulcerative colitis, or certain or probable ulcerated proctitis, unclassified colitis, diagnosed between 01/01 / 1988 and 12/31/2011, with an age at diagnosis of less than 17 years (definition of the pediatric cohort of the EPIMAD Registry)
- Patient residing in the area of the EPIMAD registry: Nord, Pas-de-Calais, Somme or Seine-Maritime
- Patient not opposed to the research
- Patient not having objected to the use of their data for ancillary studies when registering in the EPIMAD register
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this project is to assess the occupational insertion of these adult patients with pediatric-onset IBD and to compare it with the general population.
The secondary objectives are:
Read more
- to assess the level of education and compare it to that of the general population
- to assess occupational insertion and the educational level according to:
- The disease (Crohn's disease, ulcerative colitis or unclassified colitis)
- sex
- Age at diagnosis (<or ≥ 10 years)
- The occurence of surgery, the location of the disease, the treatments undertaken
- Quality of life
- Evaluate the patient's feelings about the impact of his illness on occupational insertion and the educational level
- To describe the quality of life of patients in relation to disease activity and health states (QALY calculation)
- To assess the responsivness to change of the functional handicap score IBD-DI (n = 200 patients)
Read the detailed description
Chronic inflammatory bowel diseases (IBD) are responsible for high morbidity and impaired quality of life of patients throughout disease course.
Numerous studies have shown the impact of the disease on the quality of life of patients with IBD. However, very little data is available on the level of education and professional integration of patients who started their IBD in childhood.
The hypothesis behind the study project is that the level of education and consequently the professional integration of patients with early pediatric IBD: 1) could be different from those of the general population; 2) and that these differences could be influenced by the nature of IBD, the age of its onset and its main characteristics.
The main objective of this project is to assess the professional integration of these adult patients with pediatric-onset IBD and to compare it with the general population.
- Conditions
- Crohn Disease, Ulcerative Colitis
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of active workers in employment
Rate of active workers in employment collected using a standardized self-questionnaire
Measured: through study completion, an average of 18 months
Secondary outcomes (12)
Educational level
Description of educational level collected using a standardized self-administered questionnaire
Measured: through study completion, an average of 18 months
Association between occupational insertion and disease variables
Associated factors are : disease type (Crohn / Ulcerative colitis), gender, location of the disease at diagnosis, surgery, treatments, age at diagnosis
Measured: through study completion, an average of 18 months
Association between occupational insertion and quality of life
Quality of life as measured by SIBDQ questionnaire.
Measured: through study completion, an average of 18 months
Association between educational level and disease variables
Associated factors are : disease type (Crohn / Ulcerative colitis), gender, location of the disease at diagnosis, surgery, treatments, age at diagnosis
Measured: through study completion, an average of 18 months
Association between educational level and quality of life
Quality of life as measured by SIBDQ questionnaire.
Measured: through study completion, an average of 18 months
Percentage of patients for whom the disease had an influence on the choice of studies
This question is directly asked to the patient and reflects its own feeling
Measured: through study completion, an average of 18 months
Percentage of patients for whom the disease had an influence on the course of the studies
This question is directly asked to the patient and reflects its own feeling
Measured: through study completion, an average of 18 months
Percentage of patients for whom the disease had an influence on the choice of profession
This question is directly asked to the patient and reflects its own feeling
Measured: through study completion, an average of 18 months
Quality of life as measured by EQ5D-5L questionnaire
Quality of life as measured by EQ5D-5L questionnaire and transformed into utility according to French reference values. Quality of life will be described according to age, disease activity and surgery.
Measured: through study completion, an average of 18 months
Disease activity for Crohn's patients
As measured by HBI (Harvey-Bradshaw Index). Disease activity will be used to describe quality of life according to disease state and to assessed sensitivity to change of IBD-Disability Index.
Measured: through study completion, an average of 18 months
Disease activity for Ulcerative Colitis patients
As measured by SCCAI questionnaire (Simple Clinical Colitis Activity Index). Disease activity will be used to describe quality of life according to disease state and to assessed sensitivity to change of IBD-Disability Index.
Measured: through study completion, an average of 18 months
Disability in 200 patients
As measured by IBD-DI (IBD Disability Index) in 200 patients previously questioned in 2012 in order to address the question of sensitivity to change of IBD-DI. Measure of change is disease activity as measured by HBI-Index for Crohn's patients and SCCAI for Ulcerative Colitis patients.
Measured: through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start28 Nov 2019
- Primary completion28 Jan 2023
- Study completion28 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Dominique Turck, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887428
- Sponsor's protocol ID
- 2017_19
- Other IDs
- 2017-A03397-46
- Acronym
- PROMICI
- Status last verified
- May 2026
- First submitted
- 10 May 2021
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Insertion and Educational Level of Adult Patients With Pediatric Early Inflammatory Bowel Disease (IBD)
- ClinicalTrials.gov ID
- NCT04887428
- Acronym / sponsor ID
- PROMICI / 2017_19
- Conditions
- Crohn Disease, Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 28 Nov 2019 (actual)
- Primary completion
- 28 Jan 2023 (actual)
- Study completion
- 28 Jan 2023 (actual)
- First posted
- 14 May 2021 (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 main objective of this project is to assess the occupational insertion of these adult patients with pediatric-onset IBD and to compare it with the general population.
The secondary objectives are:
- to assess the level of education and compare it to that of the general population
- to assess occupational insertion and the educational level according to:
- The disease (Crohn's disease, ulcerative colitis or unclassified colitis)
- sex
- Age at diagnosis (<or ≥ 10 years)
- The occurence of surgery, the location of the disease, the treatments undertaken
- Quality of life
- Evaluate the patient's feelings about the impact of his illness on occupational insertion and the educational level
- To describe the quality of life of patients in relation to disease activity and health states (QALY calculation)
- To assess the responsivness to change of the functional handicap score IBD-DI (n = 200 patients)
Detailed description
Chronic inflammatory bowel diseases (IBD) are responsible for high morbidity and impaired quality of life of patients throughout disease course.
Numerous studies have shown the impact of the disease on the quality of life of patients with IBD. However, very little data is available on the level of education and professional integration of patients who started their IBD in childhood.
The hypothesis behind the study project is that the level of education and consequently the professional integration of patients with early pediatric IBD: 1) could be different from those of the general population; 2) and that these differences could be influenced by the nature of IBD, the age of its onset and its main characteristics.
The main objective of this project is to assess the professional integration of these adult patients with pediatric-onset IBD and to compare it with the general population.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pediatric-onset IBD (diagnosed before the age of 17) and aged over 25 at the time of the study.
Key inclusion criteria (5 listed)
- Male or female, aged 25 and over at the time of the study
- Subject listed in the EPIMAD registry suffering from certain or probable Crohn's disease, or certain or probable ulcerative colitis, or certain or probable ulcerated proctitis, unclassified colitis, diagnosed between 01/01 / 1988 and 12/31/2011, with an age at diagnosis of less than 17 years (definition of the pediatric cohort of the EPIMAD Registry)
- Patient residing in the area of the EPIMAD registry: Nord, Pas-de-Calais, Somme or Seine-Maritime
- Patient not opposed to the research
- Patient not having objected to the use of their data for ancillary studies when registering in the EPIMAD register
Key exclusion criteria (1 listed)
- None
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
Rate of active workers in employment
Time frame: through study completion, an average of 18 months
Rate of active workers in employment collected using a standardized self-questionnaire
12 secondary outcomes
Educational level
Time frame: through study completion, an average of 18 months
Association between occupational insertion and disease variables
Time frame: through study completion, an average of 18 months
Association between occupational insertion and quality of life
Time frame: through study completion, an average of 18 months
Association between educational level and disease variables
Time frame: through study completion, an average of 18 months
Association between educational level and quality of life
Time frame: through study completion, an average of 18 months
Percentage of patients for whom the disease had an influence on the choice of studies
Time frame: through study completion, an average of 18 months
Percentage of patients for whom the disease had an influence on the course of the studies
Time frame: through study completion, an average of 18 months
Percentage of patients for whom the disease had an influence on the choice of profession
Time frame: through study completion, an average of 18 months
Quality of life as measured by EQ5D-5L questionnaire
Time frame: through study completion, an average of 18 months
Disease activity for Crohn's patients
Time frame: through study completion, an average of 18 months
Disease activity for Ulcerative Colitis patients
Time frame: through study completion, an average of 18 months
Disability in 200 patients
Time frame: through study completion, an average of 18 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 22 May 2026.
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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.
Dominique Turck, MD,PhD principal investigator
University Hospital, Lille
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 Crohn Disease and Ulcerative Colitis, run by University Hospital, Lille at 1 site in France.
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 5 inclusion and 1 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 22 May 2026. 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 France. 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?
Rate of active workers in employment (time frame: through study completion, an average of 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.