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Recruiting NCT07670975

NCT07670975 Resting Energy Expenditure in Pediatric Patients With Inflammatory Bowel Disease (REE-MICI)

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Clinical Trial Summary
NCT ID NCT07670975
Status Recruiting
Phase
Sponsor Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Condition Crohn Disease Colitis
Study Type OBSERVATIONAL
Enrollment 50 participants
Start Date 2025-05-01
Primary Completion 2027-03

Eligibility & Interventions

Sex All sexes
Min Age 6 Years
Max Age 17 Years
Study Type OBSERVATIONAL
Interventions
Indirect Calorimetry

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 50 participants in total. It began in 2025-05-01 with a primary completion date of 2027-03.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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 Criteria

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

Contact & Investigator

Central Contact

Clinical Trial Center (CTC)

✉ clinicaltrialcenter@ospedale.al.it

📞 0131206893

Frequently Asked Questions

Who can join the NCT07670975 clinical trial?

This trial is open to participants of all sexes, aged 6 Years or older, up to 17 Years, studying Crohn Disease Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07670975 currently recruiting?

Yes, NCT07670975 is actively recruiting participants. Contact the research team at clinicaltrialcenter@ospedale.al.it for enrollment information.

Where is the NCT07670975 trial being conducted?

This trial is being conducted at Alessandria, Italy.

Who is sponsoring the NCT07670975 clinical trial?

NCT07670975 is sponsored by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria. The trial plans to enroll 50 participants.

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