Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-01 @ 4:12 PM
Study NCT ID:
NCT06723418
Status:
RECRUITING
Last Update Posted:
2024-12-16
First Post:
2024-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and Validation of a New Paediatric Inflammatory Bowel Disease NUTrition Risk Score (PIBD-NUTS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2024-12-02', 'studyFirstSubmitQcDate': '2024-12-02', 'lastUpdatePostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the performance of an existing nutritional screening tool (PYMS) in paediatric IBD patients at different international settings.', 'timeFrame': '1 year', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ulcerative colitis', 'Crohns disease'], 'conditions': ['Inflammatory Bowel Diseases (IBD)', 'Crohns Disease', 'Ulcerative Colitis (UC)']}, 'referencesModule': {'references': [{'pmid': '20398432', 'type': 'BACKGROUND', '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.'}, {'pmid': '21388725', 'type': 'BACKGROUND', '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.'}, {'pmid': '29050646', 'type': 'BACKGROUND', '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.'}, {'pmid': '35258497', 'type': 'BACKGROUND', '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.'}, {'pmid': '21564345', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': "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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All IBD (Crohns disease \\& ulcerative colitis) patients (4-18 years) either admitted to hospital, or visiting their gastroenterologist's outpatient clinic for routine visits are eligible.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pediatric patients with either Crohn's disease or ulcerative colitis between the ages of (4-18 years)\n\nExclusion Criteria:\n\n* Pediatric patients with IBDU"}, 'identificationModule': {'nctId': 'NCT06723418', 'acronym': 'PIBD-NUTS', 'briefTitle': 'Development and Validation of a New Paediatric Inflammatory Bowel Disease NUTrition Risk Score (PIBD-NUTS)', 'organization': {'class': 'OTHER', 'fullName': 'University of Glasgow'}, 'officialTitle': 'Development and Validation of a New Paediatric Inflammatory Bowel Disease NUTrition Risk Score (PIBD-NUTS)', 'orgStudyIdInfo': {'id': 'PIBD-NUTS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric patients with Inflammatory Bowel Disease (Crohns disease & ulcerative colitis)', 'interventionNames': ['Other: Malnutriton Screening Tool (PYMS)']}], 'interventions': [{'name': 'Malnutriton Screening Tool (PYMS)', 'type': 'OTHER', 'description': 'In a pilot implementation study, PYMS will be used on children with IBD attending the outpatient and inpatient hospital clinics', 'armGroupLabels': ['Pediatric patients with Inflammatory Bowel Disease (Crohns disease & ulcerative colitis)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Salzburg', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Anna-Maria schneider', 'role': 'CONTACT', 'email': 'an.schneider@salk.at'}], 'facility': 'Salzburg University Hospital', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'city': 'Zagreb', 'status': 'RECRUITING', 'country': 'Croatia', 'contacts': [{'name': 'Iva Hojsak Tarihinde', 'role': 'CONTACT', 'email': 'ivahojsak@gmail.com'}], 'facility': 'Children's Hospital Zagreb', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Giessen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jan De Laffolie', 'role': 'CONTACT', 'email': 'Jan.DeLaffolie@paediat.med.uni-giessen.de', 'phone': '0641 - 985 43400'}], 'facility': 'University of Giessen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'city': 'Rotterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Hankje Escher', 'role': 'CONTACT', 'email': 'j.escher@erasmusmc.nl', 'phone': '0107036111'}], 'facility': 'Erasmus MC university medical centre', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Jaroslaw kierkus', 'role': 'CONTACT', 'email': 'j.kierkus@med-net.pl'}], 'facility': "The Children's Memorial Health Institute", 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Bristol', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Kwang Yang Lee', 'role': 'CONTACT', 'email': 'kwangyang.lee@uhbw.nhs.uk'}], 'facility': 'University Hospital Bristol and Weston', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'city': 'Edinburgh', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Richard Professor Russell', 'role': 'CONTACT', 'email': 'richard.russell@nhs.scot', 'phone': '+44 131 312 0431 or 0430'}], 'facility': 'Royal Hospital for Children and Young People', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Fevronia Kiparissi', 'role': 'CONTACT', 'email': 'Fevronia.Kiparissi@gosh.nhs.uk', 'phone': '0207 405 9200'}], 'facility': 'Great Ormond Street Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Konstantinos Gerasimidis', 'role': 'CONTACT', 'email': 'konstantinos.gerasimidis@glasgow.ac.uk', 'phone': '0044 141 201 8689'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Glasgow', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Clinical Nutrition', 'investigatorFullName': 'Dr Konstantinos Gerasimidis', 'investigatorAffiliation': 'University of Glasgow'}}}}