Resting Energy Expenditure in Pediatric Patients With Inflammatory Bowel Disease (REE-MICI) (REE-MICI)
Measurement of Basal Metabolism in Patients With Crohn's Disease and Ulcerative Colitis and Correlation With Disease Activity.
研究概览
详细说明
Inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, are associated with an increased risk of malnutrition and growth impairment in pediatric patients. Chronic inflammation, reduced oral intake, malabsorption, and increased metabolic demand may contribute to altered nutritional status and increased resting energy expenditure (REE).
Resting energy expenditure represents the amount of energy required to maintain basic physiological functions at rest and accounts for most daily energy consumption. Accurate evaluation of REE is important to optimize nutritional support and avoid underfeeding or overfeeding in children with IBD.
This study is a national multicenter prospective observational no-profit study involving pediatric patients aged 6 to 17 years with a new diagnosis of IBD according to ECCO/ESPGHAN criteria. Approximately 50 patients are expected to be enrolled.
REE will be measured using indirect calorimetry and compared with predictive equations. Clinical and laboratory parameters routinely collected during standard clinical care will also be evaluated, including disease activity indices (PUCAI/PCDAI), anthropometric measurements, biochemical parameters, fecal calprotectin, dietary intake, physical activity questionnaires, and endoscopic scores.
Data will be collected at diagnosis, after induction therapy, and during follow-up visits. The study aims to identify possible correlations between REE, disease activity, and dietary or pharmacological treatments in pediatric patients with IBD.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Clinical Trial Center (CTC)
- 电话号码:0131206893
- 邮箱:clinicaltrialcenter@ospedale.al.it
学习地点
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Piedmont
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Alessandria、Piedmont、意大利、15121
- 招聘中
- Pediatric Unit
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接触:
- Clinical Trial Center
- 电话号码:0131206893
- 邮箱:clinicaltrialcenter@ospedale.al.it
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参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Pediatric patients aged 6 to 17 years
- New diagnosis of inflammatory bowel disease, including Crohn disease or ulcerative colitis, according to ECCO/ESPGHAN criteria
- Written informed consent signed by parents or legal guardians
Exclusion Criteria:
- Intestinal surgery within 6 weeks before the first evaluation
- Parenteral or enteral nutrition within 6 weeks before the first evaluation
- Eating disorders or other chronic diseases associated with possible malabsorption
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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Pediatric IBD Patients
Pediatric patients aged 6 to 17 years with a new diagnosis of inflammatory bowel disease, including Crohn disease and ulcerative colitis, enrolled in this prospective multicenter observational study.
Participants undergo resting energy expenditure assessment by indirect calorimetry together with routine clinical, laboratory, anthropometric, nutritional, and disease activity evaluations during follow-up.
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Resting energy expenditure (REE) assessment performed using indirect calorimetry in pediatric patients with inflammatory bowel disease during routine clinical follow-up.
Measurements are obtained under resting conditions after fasting and are used to evaluate energy metabolism and its relationship with disease activity and treatments.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Resting Energy Expenditure measured by indirect calorimetry
大体时间:Baseline, 2 months, and 9 months after diagnosis
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Assessment of resting energy expenditure (REE) in pediatric patients with inflammatory bowel disease using indirect calorimetry and comparison with predictive equations.
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Baseline, 2 months, and 9 months after diagnosis
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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