Body Composition in Children With Inflammatory Bowel Disease

NCT02745457 | Completed

• 1 other identifier: BodPod IBD
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• To assess the accuracy of ADP in comparison to DEXA based measurement of body composition in children with IBD

  24 months

• To evaluate the correlation of body composition to skin fold and mid arm circumference measurements in children with IBD

  24 months

• To evaluate the correlation of body composition with BMI

  24 months

• To evaluate the correlation of body composition with disease activity

  24 months

• To evaluate the correlation of body composition with physical activity

  24 months

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children at age 6 year to 17 years diagnosed with IBD

You may qualify if:

• Diagnosis of IBD
• Age: 6 - 17 years ( inclusive)
• Informed consent

You may not qualify if:

• Pregnancy
• Non IBD associated chronic diseases
• Morbid obesity

Sponsors & Collaborators

• Schneider Children's Medical Center, Israel: lead

Study Sites (1)

Schenider Children's Medical Center

Petah Tikva, 4920235, Israel

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of IBD program

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: April 20, 2016
• Study Start: April 1, 2016
• Primary Completion: September 1, 2021
• Study Completion: July 31, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

IL (1)