Inflammatory Bowel DiseasesMICI SchoolNCT03270267
Chronic Inflammatory Bowel Diseases (IBD) and School Absenteeism
An observational study of Inflammatory Bowel Diseases, run by Rennes University Hospital at 1 site in France.
Trial summary
Study of the causes and rate of school absenteeism in children and adolescents with Inflammatory Bowel Disease. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Questionnaires
- How many people
- 108 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2016to 28 Feb 2018
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with IBD
Who may be able to join
- Child aged 6 to 18 years old
- Child with definite diagnosis of IBD for at least 6 months
- Follow-up by a gastroenterologist of Rennes University Hospital on a regular basis (at least 2 annual consultations)
- Non-opposition of the child and the parents
Who cannot join
- School leaving
- Student at the University
- Other serious disease outside IBD preventing normal schooling
- Refusal of participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Inflammatory Bowel Diseases and School Absenteeism
Study of the causes and rate of school absenteeism in children and adolescents with Inflammatory Bowel Disease.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Questionnaires
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with IBD | Not described Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days of absence from school due to IBD
Measured: Month 10
Secondary outcomes (2)
Comparison of the rate of school absenteeism of a child with IBD to the data of the school academy where she/he is enrolled
Measured: Month 10
Study of repercussion of the number of days of absence due to IBD on school results
Measured: Month 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start1 Sep 2016
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270267
- Sponsor's protocol ID
- 35RC16_3035_MICI School
- Acronym
- MICI School
- Status last verified
- Mar 2019
- First submitted
- 30 Aug 2017
- Last updated
- 11 Mar 2019
- 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 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Inflammatory Bowel Diseases and School Absenteeism
- ClinicalTrials.gov ID
- NCT03270267
- Acronym / sponsor ID
- MICI School / 35RC16_3035_MICI School
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 1 Sep 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.
Study of the causes and rate of school absenteeism in children and adolescents with Inflammatory Bowel Disease.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with IBD | – | Other: Questionnaires |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with IBD
Key inclusion criteria (4 listed)
- Child aged 6 to 18 years old
- Child with definite diagnosis of IBD for at least 6 months
- Follow-up by a gastroenterologist of Rennes University Hospital on a regular basis (at least 2 annual consultations)
- Non-opposition of the child and the parents
Key exclusion criteria (4 listed)
- School leaving
- Student at the University
- Other serious disease outside IBD preventing normal schooling
- Refusal of participation
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 |
|---|---|---|
| Questionnaires | Other | Patients with IBD |
Primary outcome
Number of days of absence from school due to IBD
Time frame: Month 10
2 secondary outcomes
Comparison of the rate of school absenteeism of a child with IBD to the data of the school academy where she/he is enrolled
Time frame: Month 10
Study of repercussion of the number of days of absence due to IBD on school results
Time frame: Month 10
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 11 Mar 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Diseases, run by Rennes University Hospital 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 4 inclusion and 4 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 11 Mar 2019. 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?
Number of days of absence from school due to IBD (time frame: Month 10). 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 11 Mar 2019.