Clinical trial NCT06723418: Development and Validation of a New Paediatric Inflammatory Bowel Disease NUTrition Risk Score (PIBD-NUTS)
Official title: Development and Validation of a New Paediatric Inflammatory Bowel Disease NUTrition Risk Score (PIBD-NUTS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Diseases (IBD)
Crohns Disease
Ulcerative Colitis (UC)
Keywords: Ulcerative colitis
Crohns disease
Lead sponsor: University of Glasgow
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 2000
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All IBD (Crohns disease \&amp; ulcerative colitis) patients (4-18 years) either admitted to hospital, or visiting their gastroenterologist's outpatient clinic for routine visits are eligible.

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: the performance of an existing nutritional screening tool (PYMS) in paediatric IBD patients at different international settings.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Salzburg University Hospital
city: Zagreb
country: Croatia
facility: Children&#39;s Hospital Zagreb
city: Giessen
country: Germany
facility: University of Giessen
city: Rotterdam
country: Netherlands
facility: Erasmus MC university medical centre
city: Warsaw
country: Poland
facility: The Children's Memorial Health Institute
city: Bristol
country: United Kingdom
facility: University Hospital Bristol and Weston
city: Edinburgh
country: United Kingdom
facility: Royal Hospital for Children and Young People
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
Study officials:
References:
citation: Gerasimidis K, Keane O, Macleod I, Flynn DM, Wright CM. A four-stage evaluation of the Paediatric Yorkhill Malnutrition Score in a tertiary paediatric hospital and a district general hospital. Br J Nutr. 2010 Sep;104(5):751-6. doi: 10.1017/S0007114510001121. Epub 2010 Apr 19.
citation: Gerasimidis K, Macleod I, Maclean A, Buchanan E, McGrogan P, Swinbank I, McAuley M, Wright CM, Flynn DM. Performance of the novel Paediatric Yorkhill Malnutrition Score (PYMS) in hospital practice. Clin Nutr. 2011 Aug;30(4):430-5. doi: 10.1016/j.clnu.2011.01.015. Epub 2011 Mar 9.
citation: Ng SC, Shi HY, Hamidi N, Underwood FE, Tang W, Benchimol EI, Panaccione R, Ghosh S, Wu JCY, Chan FKL, Sung JJY, Kaplan GG. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet. 2017 Dec 23;390(10114):2769-2778. doi: 10.1016/S0140-6736(17)32448-0. Epub 2017 Oct 16.
citation: Hulst JM, Huysentruyt K, Gerasimidis K, Shamir R, Koletzko B, Chourdakis M, Fewtrell M, Joosten KF; Special Interest Group Clinical Malnutrition of ESPGHAN. A Practical Approach to Identifying Pediatric Disease-Associated Undernutrition: A Position Statement from the ESPGHAN Special Interest Group on Clinical Malnutrition. J Pediatr Gastroenterol Nutr. 2022 May 1;74(5):693-705. doi: 10.1097/MPG.0000000000003437. Epub 2022 Mar 3.
citation: Gerasimidis K, McGrogan P, Edwards CA. The aetiology and impact of malnutrition in paediatric inflammatory bowel disease. J Hum Nutr Diet. 2011 Aug;24(4):313-26. doi: 10.1111/j.1365-277X.2011.01171.x. Epub 2011 May 13.