MedDataX Logo

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

NCT ID: NCT06723418

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-15

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inflammatory Bowel Diseases (IBD) Crohns Disease Ulcerative Colitis (UC)

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Ulcerative colitis Crohns disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pediatric patients with Inflammatory Bowel Disease (Crohns disease & ulcerative colitis)

Malnutriton Screening Tool (PYMS)

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Malnutriton Screening Tool (PYMS)

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Glasgow

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Konstantinos Gerasimidis

Professor of Clinical Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Salzburg University Hospital

Salzburg, , Austria

Site Status RECRUITING

Children's Hospital Zagreb

Zagreb, , Croatia

Site Status RECRUITING

University of Giessen

Giessen, , Germany

Site Status RECRUITING

Erasmus MC university medical centre

Rotterdam, , Netherlands

Site Status RECRUITING

The Children's Memorial Health Institute

Warsaw, , Poland

Site Status RECRUITING

University Hospital Bristol and Weston

Bristol, , United Kingdom

Site Status RECRUITING

Royal Hospital for Children and Young People

Edinburgh, , United Kingdom

Site Status RECRUITING

Great Ormond Street Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Austria Croatia Germany Netherlands Poland United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Konstantinos Gerasimidis

Role: CONTACT

Phone: 0044 141 201 8689

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Anna-Maria schneider

Role: primary

Iva Hojsak Tarihinde

Role: primary

Jan De Laffolie

Role: primary

Hankje Escher

Role: primary

Jaroslaw kierkus

Role: primary

Kwang Yang Lee

Role: primary

Richard Professor Russell

Role: primary

Fevronia Kiparissi

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 20398432 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21388725 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29050646 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35258497 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21564345 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PIBD-NUTS

Identifier Type: -

Identifier Source: org_study_id