Crohn's DiseaseNCT02745457
Body Composition in Children With Inflammatory Bowel Disease
An observational study of Crohn's Disease and Ulcerative Colitis, run by Schneider Children's Medical Center, Israel at 1 site in Israel.
Trial summary
Background: Growth impairment is commonly seen in children diagnosed with inflammatory bowel diseases (IBD), mainly those with Crohn's disease (CD). There is general consensus in the literature that body composition, composed of fat mass and lean mass is altered in children with IBD compared with controls. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis
- How many people
- 72 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2016to 31 Jul 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children at age 6 year to 17 years diagnosed with IBD
Who may be able to join
- Diagnosis of IBD
- Age: 6 - 17 years ( inclusive)
- Informed consent
Who cannot join
- Pregnancy
- Non IBD associated chronic diseases
- Morbid obesity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Natural Course and the Effect of Treatment on Body Composition in Children With Inflammatory Bowel Disease
Background: Growth impairment is commonly seen in children diagnosed with inflammatory bowel diseases (IBD), mainly those with Crohn's disease (CD). There is general consensus in the literature that body composition, composed of fat mass and lean mass is altered in children with IBD compared with controls. Evidence regarding the effect of different therapeutic approaches on body composition in children with IBD is scarce and inconsistent. Furthermore, most studies used anthropometric measures and dual energy X-ray absorptiometry (DEXA) for body composition assessment, while information on the usefulness of air displacement plethysmography (ADP) for this assessment is lacking.
Objectives: To assess body composition in children with IBD by ADP and DEXA at diagnosis and at various intervals during follow up.
Read more
Design: A prospective cohort study. Setting: Pediatric gastroenterology institute, Schneider Children's Hospital.
Participants: Children 6 year to 17 years who are diagnosed with either CD or ulcerative colitis (UC).
Main outcome measures: Accuracy of ADP in comparison to DEXA and percentage of fat mass and lean mass at diagnosis and during treatment.
Secondary outcome measures: Correlation of body composition to skin fold, mid arm circumference measurements, BMI, inflammatory markers, gender, disease activity and physical activity.
Read the detailed description
Children diagnosed with either Crohn's disease (CD) or Ulcerative Colitis (UC) under follow-up at the Pediatric gastroenterology institute, Schneider Children's Hospital, will be enrolled. Patients can be enrolled at diagnosis or at any time point during follow-up. Patients' characteristics will be retrieved from their medical files including demographic details, disease phenotype, anthropometric measures, laboratory evaluation, complication and therapeutic regimens. At enrollment all patients will perform body composition assessment by air displacement plethysmography (ADP) and DEXA (no greater than 7 days between the 2 methods of measurement). At one and two years following initial assessment ADP measurement will be repeated, mid arm circumference and skin fold measurements will be taken and the patient will fill a physical activity questionnaire. Disease activity score (either Pediatric Crohn's Disease Activity Index for CD or Pediatric Ulcerative Colitis Activity Index for UC) will be calculated. Similar evaluation will be performed prior and immediately following exclusive enteral nutrition or corticosteroid courses and prior to any biologic therapy initiation.
- Conditions
- Crohn's 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.
To evaluate the change in body composition accorging to treatment treatment is children with IBD over the course of 2 years
Percentage of fat mass and lean mass at diagnosis and during treatment
Measured: 24 months
Secondary outcomes (5)
To assess the accuracy of ADP in comparison to DEXA based measurement of body composition in children with IBD
To assess the validity of ADP in children with IBD using DEXA as a gold standard for body composition
Measured: 24 months
To evaluate the correlation of body composition to skin fold and mid arm circumference measurements in children with IBD
Measured: 24 months
To evaluate the correlation of body composition with BMI
Measured: 24 months
To evaluate the correlation of body composition with disease activity
Measured: 24 months
To evaluate the correlation of body composition with physical activity
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion1 Sep 2021
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schneider Children's Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Assa, Schneider Children's Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745457
- Sponsor's protocol ID
- BodPod IBD
- Status last verified
- Nov 2023
- First submitted
- 13 Apr 2016
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natural Course and the Effect of Treatment on Body Composition in Children With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT02745457
- Acronym / sponsor ID
- BodPod IBD
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Schneider Children's Medical Center, IsraelUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 20 Apr 2016 (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.
Background: Growth impairment is commonly seen in children diagnosed with inflammatory bowel diseases (IBD), mainly those with Crohn's disease (CD). There is general consensus in the literature that body composition, composed of fat mass and lean mass is altered in children with IBD compared with controls. Evidence regarding the effect of different therapeutic approaches on body composition in children with IBD is scarce and inconsistent. Furthermore, most studies used anthropometric measures and dual energy X-ray absorptiometry (DEXA) for body composition assessment, while information on the usefulness of air displacement plethysmography (ADP) for this assessment is lacking.
Objectives: To assess body composition in children with IBD by ADP and DEXA at diagnosis and at various intervals during follow up.
Design: A prospective cohort study. Setting: Pediatric gastroenterology institute, Schneider Children's Hospital.
Participants: Children 6 year to 17 years who are diagnosed with either CD or ulcerative colitis (UC).
Main outcome measures: Accuracy of ADP in comparison to DEXA and percentage of fat mass and lean mass at diagnosis and during treatment.
Secondary outcome measures: Correlation of body composition to skin fold, mid arm circumference measurements, BMI, inflammatory markers, gender, disease activity and physical activity.
Detailed description
Children diagnosed with either Crohn's disease (CD) or Ulcerative Colitis (UC) under follow-up at the Pediatric gastroenterology institute, Schneider Children's Hospital, will be enrolled. Patients can be enrolled at diagnosis or at any time point during follow-up. Patients' characteristics will be retrieved from their medical files including demographic details, disease phenotype, anthropometric measures, laboratory evaluation, complication and therapeutic regimens. At enrollment all patients will perform body composition assessment by air displacement plethysmography (ADP) and DEXA (no greater than 7 days between the 2 methods of measurement). At one and two years following initial assessment ADP measurement will be repeated, mid arm circumference and skin fold measurements will be taken and the patient will fill a physical activity questionnaire. Disease activity score (either Pediatric Crohn's Disease Activity Index for CD or Pediatric Ulcerative Colitis Activity Index for UC) will be calculated. Similar evaluation will be performed prior and immediately following exclusive enteral nutrition or corticosteroid courses and prior to any biologic therapy initiation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children at age 6 year to 17 years diagnosed with IBD
Key inclusion criteria (3 listed)
- Diagnosis of IBD
- Age: 6 - 17 years ( inclusive)
- Informed consent
Key exclusion criteria (3 listed)
- Pregnancy
- Non IBD associated chronic diseases
- Morbid obesity
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
To evaluate the change in body composition accorging to treatment treatment is children with IBD over the course of 2 years
Time frame: 24 months
Percentage of fat mass and lean mass at diagnosis and during treatment
5 secondary outcomes
To assess the accuracy of ADP in comparison to DEXA based measurement of body composition in children with IBD
Time frame: 24 months
To evaluate the correlation of body composition to skin fold and mid arm circumference measurements in children with IBD
Time frame: 24 months
To evaluate the correlation of body composition with BMI
Time frame: 24 months
To evaluate the correlation of body composition with disease activity
Time frame: 24 months
To evaluate the correlation of body composition with physical activity
Time frame: 24 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 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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 Crohn's Disease and Ulcerative Colitis, run by Schneider Children's Medical Center, Israel at 1 site in Israel.
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 3 inclusion and 3 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 Nov 2023. 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 Israel. 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?
To evaluate the change in body composition accorging to treatment treatment is children with IBD over the course of 2 years (time frame: 24 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 Nov 2023.