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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-17
SponsorAzienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Pediatric patients aged 6 to 17 years with newly diagnosed inflammatory bowel disease, including Crohn disease and ulcerative colitis, recruited from participating Italian centers with availability of indirect calorimetry assessment.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Indirect Calorimetry

    Diagnostic test

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Pediatric IBD Patients1 intervention

Trial outcomes

Primary outcomes

1

Resting Energy Expenditure measured by indirect calorimetry

Assessment of resting energy expenditure (REE) in pediatric patients with inflammatory bowel disease using indirect calorimetry and comparison with predictive equations.

Time frame
Baseline, 2 months, and 9 months after diagnosis

Secondary outcomes

Other outcomes

Sponsors and contacts

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