Crohn's EnteritisMICI-FITNCT04647578
Physical Fitness Levels in Children and Adolescents With Chronic Inflammatory Bowel Disease (CIBD): Crohn's Disease, Ulcerative Colitis, Chronic Unclassified Colitis
An observational study of Crohn's Enteritis and Crohn Disease, run by University Hospital, Lille at 1 site in France.
Trial summary
Inflammatory bowel diseases (IBDs), including Crohn's disease (CD), ulcerative colitis (UC) and IBD-unclassified (IBD-U), are characterised by chronic inflammation of the gastrointestinal tract. Over the past 50 years, the incidence of IBD has increased globally, with the highest increase in industrialised countries. Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn's Enteritis, Crohn Disease, Inflammatory Bowel Diseases
- What is being tested?
- GT3X Actigraph accelerometer.
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2020to 31 Mar 2022
- 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 10 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy children and adolescents with IBD (Crohn's disease, ulcerative colitis and chronic ulcerative colitis).
Who may be able to join
- For children with IBD:
- boy or girl aged 10 to 17 years old when signing the consent.
- obtain the consent of participation of the child and the signed inform consent of the two parents or a legal representative.
- Patient benefiting from health care- has IBD (Crohn's disease, ulcerative colitis and unclassified chronic colitis) for at least 6 months.
- Contactable by phone
- For healthy controls:
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- Patient without IBD
- Boy or girl aged 10 to 17 years old when signing the consent.
- obtain the consent of participation of the child and the signed inform consent of the two parents or a legal representative.
- Patient benefiting from health care
Who cannot join
- For children with IBD:
- Acute intercurrent events at the time of inclusion which may lead to a decrease in physical fitness and activity, according to the judgment of the investigator (fractures, recent arthritis, ano-perineal lesions, severe dermatological lesions).
- Patients with a disease a mild activity (PCDAI score > 30 for children with Crohn disease and PUCAI > 35 for children with ulcerative colitis.
- Chronic, acute or intermittent diseases (other than IBD) that may lead to a decrease in physical activity (Example: fracture, paralysis, blindness ...).
- Refusal of the child's participation in the protocol.
- Refusal of one of the child's parents to participate in the protocol.
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- Participation in another interventional study.
- Pregnant or lactating women.
- Patient under protection of justice.
- For healthy controls:
- Chronic, acute or intermittent diseases (other than IBD) that may lead to a decrease in physical fitness and activity (Example: fracture, paralysis, blindness ...).
- Refusal of the child's participation in the protocol.
- Refusal of one of the child's parents to participate in the protocol.
- Participation in another interventional study.
- Pregnant or lactating women.
- Patient under protection of justice.
Trial locations and contacts
1 site in 1 country.
About this study
Inflammatory bowel diseases (IBDs), including Crohn's disease (CD), ulcerative colitis (UC) and IBD-unclassified (IBD-U), are characterised by chronic inflammation of the gastrointestinal tract. Over the past 50 years, the incidence of IBD has increased globally, with the highest increase in industrialised countries. During the last 25 years, the incidence of IBD has increased dramatically among teenagers in northern France, with an increase of 126% and 156% for CD and UC, respectively.
Physical fitness is a set of attributes related to a person's ability to perform physical activities that require aerobic capacity, endurance, strength or flexibility and is determined by a combination of regular physical activity and genetically inherited ability. Physical fitness, widely recognised as an important health determinant, plays an important role in growth and development. Due to the evidence-based importance of physical fitness for young people's health status, attention should be paid to the assessment of physical fitness at these ages and whatever the health status.
At this time, there is no study on the assessment of physical fitness in IBD pediatric patient.
- Conditions
- Crohn's Enteritis, Crohn Disease, Inflammatory Bowel Diseases, Colitis, Ulcerative, Granulomatous Enteritis, Granulomatous Colitis
- Being tested
- GT3X Actigraph accelerometer.
- Keywords
- Pediatric, IBD, physical fitness
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases, Colitis, Ulcerative, Proctocolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GT3X Actigraph accelerometer.Device
GT3X Actigraph accelerometer during 7 days
| Study group | Role | What they receive |
|---|---|---|
| Child with IBD | Not described Receives: Device: GT3X Actigraph accelerometer. | |
| Healthy child witnesses | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in cardiorespiratory fitness (expressed in ml/kg/min) between children and adolescents with IBD and age-, BMI and sex-matched healthy controls.
Measured: At 7 days
Secondary outcomes (7)
Difference in muscular endurance, strength, speed/agility, flexibility, strength between children and adolescents with IBD and age-, BMI and sex-matched healthy controls
Measured: Baseline, at 7 days
Disease activity according to PCDAI scores
(Pediatric Crohn Disease Activity Index)
Measured: Baseline, at 7 days
Disease activity according to PUCAI scores
Pediatric Ulcerative Colitis Activity Index
Measured: Baseline, at 7 days
Percentage of IBD children and adolescents with a cardiovascular risk disease
Measured: Baseline, at 7 days
Correlation between quality of life and physical fitness in children and adolescent with IBD
Measured: Baseline, at 7 days
Correlation between fatigue and physical fitness in children and adolescent with IBD
Measured: Baseline, at 7 days
Correlation between daily physical activity and physical fitness in children and adolescent with IBD
Measured: Baseline, at 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start1 Sep 2020
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
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 Crohn's EnteritisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Groupement Interrégional de Recherche Clinique et d'Innovation
- Responsible party
- Sponsor
- Investigators
- Dominique TURCK, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647578
- Sponsor's protocol ID
- 2019_03
- Other IDs
- 2019-A02651-56
- Acronym
- MICI-FIT
- Status last verified
- Sep 2022
- First submitted
- 24 Nov 2020
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request. Data will be made available following the conclusion of the project's period of funding.
Publications
Vanhelst J, Beghin L, Coopman S, Labreuche J, Djeddi D, Gottrand F, Turck D, Ley D. Physical fitness in children and adolescents with inflammatory bowel disease: protocol for a case-control study. BMJ Open. 2022 Oct 11;12(10):e063403. doi: 10.1136/bmjopen-2022-063403.
PubMed 36220315
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Fitness Levels in Children and Adolescents With Chronic Inflammatory Bowel Disease (CIBD): Crohn's Disease, Ulcerative Colitis, Chronic Unclassified Colitis
- ClinicalTrials.gov ID
- NCT04647578
- Acronym / sponsor ID
- MICI-FIT / 2019_03
- Conditions
- Crohn's Enteritis, Crohn Disease, Inflammatory Bowel Diseases, Colitis, Ulcerative, Granulomatous Enteritis, Granulomatous Colitis
- Keywords
- Pediatric, IBD, physical fitness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Groupement Interrégional de Recherche Clinique et d'Innovation
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 1 Dec 2020 (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.
Inflammatory bowel diseases (IBDs), including Crohn's disease (CD), ulcerative colitis (UC) and IBD-unclassified (IBD-U), are characterised by chronic inflammation of the gastrointestinal tract. Over the past 50 years, the incidence of IBD has increased globally, with the highest increase in industrialised countries. During the last 25 years, the incidence of IBD has increased dramatically among teenagers in northern France, with an increase of 126% and 156% for CD and UC, respectively.
Physical fitness is a set of attributes related to a person's ability to perform physical activities that require aerobic capacity, endurance, strength or flexibility and is determined by a combination of regular physical activity and genetically inherited ability. Physical fitness, widely recognised as an important health determinant, plays an important role in growth and development. Due to the evidence-based importance of physical fitness for young people's health status, attention should be paid to the assessment of physical fitness at these ages and whatever the health status.
At this time, there is no study on the assessment of physical fitness in IBD pediatric patient.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Child with IBD | – | Device: GT3X Actigraph accelerometer. |
| Healthy child witnesses | – | – |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy children and adolescents with IBD (Crohn's disease, ulcerative colitis and chronic ulcerative colitis).
Key inclusion criteria (10 listed)
- For children with IBD:
- boy or girl aged 10 to 17 years old when signing the consent.
- obtain the consent of participation of the child and the signed inform consent of the two parents or a legal representative.
- Patient benefiting from health care- has IBD (Crohn's disease, ulcerative colitis and unclassified chronic colitis) for at least 6 months.
- Contactable by phone
Key exclusion criteria (16 listed)
- For children with IBD:
- Acute intercurrent events at the time of inclusion which may lead to a decrease in physical fitness and activity, according to the judgment of the investigator (fractures, recent arthritis, ano-perineal lesions, severe dermatological lesions).
- Patients with a disease a mild activity (PCDAI score > 30 for children with Crohn disease and PUCAI > 35 for children with ulcerative colitis.
- Chronic, acute or intermittent diseases (other than IBD) that may lead to a decrease in physical activity (Example: fracture, paralysis, blindness ...).
- Refusal of the child's participation in the protocol.
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 |
|---|---|---|
| GT3X Actigraph accelerometer.GT3X Actigraph accelerometer during 7 days | Device | Child with IBD |
Primary outcome
Difference in cardiorespiratory fitness (expressed in ml/kg/min) between children and adolescents with IBD and age-, BMI and sex-matched healthy controls.
Time frame: At 7 days
7 secondary outcomes
Difference in muscular endurance, strength, speed/agility, flexibility, strength between children and adolescents with IBD and age-, BMI and sex-matched healthy controls
Time frame: Baseline, at 7 days
Disease activity according to PCDAI scores
Time frame: Baseline, at 7 days
Disease activity according to PUCAI scores
Time frame: Baseline, at 7 days
Percentage of IBD children and adolescents with a cardiovascular risk disease
Time frame: Baseline, at 7 days
Correlation between quality of life and physical fitness in children and adolescent with IBD
Time frame: Baseline, at 7 days
Correlation between fatigue and physical fitness in children and adolescent with IBD
Time frame: Baseline, at 7 days
Correlation between daily physical activity and physical fitness in children and adolescent with IBD
Time frame: Baseline, at 7 days
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 21 Apr 2026.
- Results publication: PubMed 36220315Vanhelst J, Beghin L, Coopman S, Labreuche J, Djeddi D, Gottrand F, Turck D, Ley D. Physical fitness in children and adolescents with inflammatory bowel disease: protocol for a case-control study. BMJ Open. 2022 Oct 11;12(10):e063403. doi: 10.1136/bmjopen-2022-063403.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request. Data will be made available following the conclusion of the project's period of funding.
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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's Enteritis and Crohn Disease, 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 10 inclusion and 16 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 21 Apr 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?
Difference in cardiorespiratory fitness (expressed in ml/kg/min) between children and adolescents with IBD and age-, BMI and sex-matched healthy controls. (time frame: At 7 days). 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 NCT04647578, 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 21 Apr 2026.