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Body Composition in Children With Inflammatory Bowel Disease

Sponsor
Schneider Children's Medical Center, Israel (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02745457
Collaborator
(none)
75
Enrollment
1
Location
72.9
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    75 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Natural Course and the Effect of Treatment on Body Composition in Children With Inflammatory Bowel Disease
    Actual Study Start Date :
    Apr 1, 2016
    Actual Primary Completion Date :
    Sep 1, 2021
    Anticipated Study Completion Date :
    Apr 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate the change in body composition accorging to treatment treatment is children with IBD over the course of 2 years [24 months]

      Percentage of fat mass and lean mass at diagnosis and during treatment

    Secondary Outcome Measures

    1. To assess the accuracy of ADP in comparison to DEXA based measurement of body composition in children with IBD [24 months]

      To assess the validity of ADP in children with IBD using DEXA as a gold standard for body composition

    2. To evaluate the correlation of body composition to skin fold and mid arm circumference measurements in children with IBD [24 months]

    3. To evaluate the correlation of body composition with BMI [24 months]

    4. To evaluate the correlation of body composition with disease activity [24 months]

    5. To evaluate the correlation of body composition with physical activity [24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of IBD

    • Age: 6 - 17 years ( inclusive)

    • Informed consent

    Exclusion Criteria:

    • Pregnancy

    • Non IBD associated chronic diseases

    • Morbid obesity

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Schenider Children's Medical Center Petach Tikva Israel 4920235

    Sponsors and Collaborators

    • Schneider Children's Medical Center, Israel

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amit Assa, Head of IBD program, Schneider Children's Medical Center, Israel
    ClinicalTrials.gov Identifier:
    NCT02745457
    Other Study ID Numbers:
    • BodPod IBD
    First Posted:
    Apr 20, 2016
    Last Update Posted:
    Sep 28, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Crohn Disease
    Inflammatory Bowel Diseases

    Study Results

    No Results Posted as of Sep 28, 2021