The Natural Course and the Effect of Treatment on Body Composition in Children With Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- To evaluate the change in body composition accorging to treatment treatment is children with IBD over the course of 2 years
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of IBD
- •Age: 6 - 17 years ( inclusive)
- •Informed consent
排除标准
- •Pregnancy
- •Non IBD associated chronic diseases
- •Morbid obesity
结局指标
主要结局
To evaluate the change in body composition accorging to treatment treatment is children with IBD over the course of 2 years
时间窗: 24 months
Percentage of fat mass and lean mass at diagnosis and during treatment
次要结局
- To evaluate the correlation of body composition with disease activity(24 months)
- To evaluate the correlation of body composition with BMI(24 months)
- 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 physical activity(24 months)
研究者
Amit Assa
Head of IBD program
Schneider Children's Medical Center, Israel