Body Composition in Children With Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

Official title:

The Natural Course and the Effect of Treatment on Body Composition in Children With Inflammatory Bowel Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02745457
• Other study ID #: BodPod IBD
• Status: Completed
• Start date: April 2016
• Est. completion date: July 31, 2023

Study information

• Verified date: November 2023
• Source: Schneider Children's Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 31, 2023
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

• Diagnosis of IBD

• Age: 6 - 17 years ( inclusive)

• Informed consent

Exclusion Criteria:

• Pregnancy

• Non IBD associated chronic diseases

• Morbid obesity

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Diseases
• Ulcerative Colitis

Locations

Country	Name	City	State
Israel	Schenider Children's Medical Center	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Schneider Children's Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 months
Secondary	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	24 months
Secondary	To evaluate the correlation of body composition to skin fold and mid arm circumference measurements in children with IBD		24 months
Secondary	To evaluate the correlation of body composition with BMI		24 months
Secondary	To evaluate the correlation of body composition with disease activity		24 months
Secondary	To evaluate the correlation of body composition with physical activity		24 months