Pediatric Unit
Alessandria, Piedmont, 15121, Italy
Location status: Recruiting
NCT Number: NCT07670975
This multicenter prospective observational non-pharmacological study aims to evaluate resting energy expenditure (REE) in pediatric patients affected by inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis. REE will be measured using indirect calorimetry and estimated using predictive equations. The study also aims to investigate the relationship between REE, disease activity, and dietary or pharmacological treatments. Clinical, laboratory, anthropometric, nutritional, and disease activity data will be collected during routine clinical follow-up at diagnosis, after induction therapy, and during follow-up visits.
Interested in participating?
Request Info6 year–17 year
All sexes
Observational
Alessandria, Piedmont, 15121, Italy
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Resting Energy Expenditure Assessment, REE Measurement
Time frame: Baseline, 2 months, and 9 months after diagnosis
Assessment of resting energy expenditure (REE) in pediatric patients with inflammatory bowel disease using indirect calorimetry and comparison with predictive equations.
Contact information is provided by the study sponsor or research team.
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Other
Measurement of Basal Metabolism in Patients With Crohn's Disease and Ulcerative Colitis and Correlation With Disease Activity.
Acronym: REE-MICI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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