- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03270267
Chronic Inflammatory Bowel Diseases (IBD) and School Absenteeism (MICI School)
March 8, 2019 updated by: Rennes University Hospital
Chronic Inflammatory Bowel Diseases and School Absenteeism
Study of the causes and rate of school absenteeism in children and adolescents with Inflammatory Bowel Disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
108
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Rennes, France, 35200
- CHU de Rennes
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with IBD
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- School leaving
- Student at the University
- Other serious disease outside IBD preventing normal schooling
- Refusal of participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with IBD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of days of absence from school due to IBD
Time Frame: Month 10
|
Month 10
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Month 10
|
Study of repercussion of the number of days of absence due to IBD on school results
Time Frame: Month 10
|
Month 10
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2016
Primary Completion (Actual)
February 28, 2018
Study Completion (Actual)
February 28, 2018
Study Registration Dates
First Submitted
August 30, 2017
First Submitted That Met QC Criteria
August 31, 2017
First Posted (Actual)
September 1, 2017
Study Record Updates
Last Update Posted (Actual)
March 11, 2019
Last Update Submitted That Met QC Criteria
March 8, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35RC16_3035_MICI School
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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