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NCT Number: NCT06723418

Development and Validation of a New Paediatric Inflammatory Bowel Disease NUTrition Risk Score (PIBD-NUTS)

Children with inflammatory bowel disease (IBD) including both Crohn's disease (CD) and ulcerative colitis (UC) can be at high risk of developing malnutrition due to the nature of their condition. It is also believed that some children with IBD, in need of nutritional care, are not identified quickly by their healthcare professionals. This may negatively affect their nutrition, disease progression and general well-being. Hence, it has been proposed that nutritional screening tools or scores (NSTs) should be used to promptly identify children needing further dietetic review and input. Although there are a few NSTs for generic use in sick children at hospital admission, NSTs or scores to use for children with IBD are currently missing. In this study, we would like to test the performance of an existing tool that is routinely used for all sick children at hospital admission (The Paediatric Yorkhill Malnutrition Score or PYMS)(5) and test whether PYMS can detect children with IBD who are at risk of malnutrition. If PYMS doesn't work well, we will develop a specific tool for children with IBD (The Paediatric IBD Nutrition Score or PIBD-NUTS).

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Key information

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Salzburg University Hospital, Salzburg, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pediatric patients with either Crohn's disease or ulcerative colitis between the ages of (4-18 years)

Exclusion criteria

  • Pediatric patients with IBDU

Treatment and study plan

Malnutriton Screening Tool (PYMS)

Other

In a pilot implementation study, PYMS will be used on children with IBD attending the outpatient and inpatient hospital clinics

Primary outcomes

  1. the performance of an existing nutritional screening tool (PYMS) in paediatric IBD patients at different international settings.

    Time frame: 1 year

    The primary outcome measure for our study is to evaluate the performance of an existing nutritional screening tool, the Paediatric Yorkhill Malnutrition Score (PYMS), specifically in pediatric IBD patients across various international settings. We aim to assess its diagnostic accuracy by examining sensitivity and specificity.

Study contacts

Contact information is provided by the study sponsor or research team.

Konstantinos Gerasimidis

CONTACT

[email protected]

0044 141 201 8689

Sponsors and collaborators

Lead sponsor

University of Glasgow

Other

Registry information

Acronym: PIBD-NUTS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2024
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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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