Resting Energy Expenditure in Pediatric Patients With Inflammatory Bowel Disease (REE-MICI)

NCT07670975 · tracked via the Priya Life Science Italy tracker

Sponsor

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Phase

Observational

Started

2025-05-01

Last updated

2026-06-26

Condition(s) studied

Crohn Disease ColitisColitis, UlcerativeInflammatory Bowel Diseases

Investigational drug(s) / intervention(s)

Indirect Calorimetry

Indirect Calorimetry: 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.

Study summary

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.

Eligibility

Sex

ALL

Min age

6 Years

Max age

17 Years

Healthy volunteers

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

Primary outcome measure(s)

Resting Energy Expenditure measured by indirect calorimetry — 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.

Trial sites (1)

Facility	City	Region	Status
Pediatric Unit	Alessandria	Piedmont	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07670975 on ClinicalTrials.gov ↗ ← All trials in Italy