An observational study in Crohn's Disease and Ulcerative Colitis, sponsored by Schneider Children's Medical Center, Israel. Completed at 1 site in Israel. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by Schneider Children's Medical Center, Israel · Observational
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.
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 72 is below the median of 162 across 608 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →Schneider Children's Medical Center, Israel is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Children at age 6 year to 17 years diagnosed with IBD
Exclusion Criteria:
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
Time frame: 24 months
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
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
Plan to share: Undecided
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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Schneider Children's Medical Center, Israel