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| Name | Class |
|---|---|
| European Commission | OTHER |
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The purpose of this study is to analyse effectiveness and safety signals of current treatment strategies in routine practice for patients with pediatric-onset inflammatory bowel disease (PIBD) and to correlate this to their individual risk factors.
In this prospective observational study children with newly diagnosed inflammatory bowel disease (IBD) will be included in the inception cohort. The primary aim of the inception cohort is to analyse the effectiveness and safety signals of current treatment strategies and to correlate them to individual risk factors. In order to capture information on rare and severe complications in PIBD as well, the safety registry was designed to estimate incidence and prevalence rates of these complications and get more insight in disease and treatment characteristics of these patients.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention due to the observational set-up of this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Predictors for outcome and treatment response or non-response | Factors predictive for outcome and treatment response or non-response This includes factors at baseline and 12 weeks after disease-onset that predict adverse outcomes (e.g. fibrostricturing disease, penetrating disease, active perianal fistula or abcess and need of surgery). | Over a period of three years after inclusion of the last patient. |
| Measure | Description | Time Frame |
|---|---|---|
| New biomarkers as classifiers of response or non-response to therapy | Part of the children in the inception cohort will deliver biological specimens to develop new biomarkers as classifiers of disease risk of complicated disease or side effects in PIBD patients, as well as predictors of (non-)response to a specific immunomodulator or biological agent. | Over a period of three years after inclusion of the last patient. |
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Inclusion Criteria Inception cohort:
Newly diagnosed patient, <18 years of age, with a likely diagnosis of IBD or a confirmed diagnosis of IBD can be included in the study. In order to be eligible to continue in the study the subject must meet all of the following criteria:
Inclusion Criteria Safety Registry:
Any child with IBD <19 years old with complications as detailed in the agreed safety monitoring list (or future updates of the list of conditions) can be reported. For the initial reporting of incident cases no patient identifiable details will be required.
Exclusion Criteria Inception cohort:
Exclusion Criteria Safety registry: none.
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Patients with paediatric-onset IBD (either Crohn's disease, ulcerative colitis or IBD-unclassified).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frank Ruemmele, MD, PhD | Contact | frank.ruemmele@nck.aphp.fr | ||
| Lissy de Ridder, MD, PhD | Contact | l.deridder@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Lissy de Ridder, MD, PhD | Erasmus Medical Center | Principal Investigator |
| Nicholas Croft, MD, PhD | Barts and the London School of Medicine, Queen Mary University of London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC - Sophia Children's Hospital | Recruiting | Rotterdam | 3015GD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21051046 | Background | Timmer A, Behrens R, Buderus S, Findeisen A, Hauer A, Keller KM, Kliemann G, Lang T, Lohr W, Rzehak P, Koletzko S; CEDATA-GPGE Study Group. Childhood onset inflammatory bowel disease: predictors of delayed diagnosis from the CEDATA German-language pediatric inflammatory bowel disease registry. J Pediatr. 2011 Mar;158(3):467-473.e2. doi: 10.1016/j.jpeds.2010.09.014. Epub 2010 Nov 4. | |
| 26835906 |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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Only in a subgroup of all patients (n=300), in specific centers, serum, stool and biopsies of (un)affected tissue of the ileum and/or colon will be collected.
| Identification of patients with rare and serious complications | Secondary outcome is to identify patients with rare and serious complications of PIBD or its treatment. | Until the end of patients recruitment, for a period of 2 years. |
| Royal Hospital London | Recruiting | London | United Kingdom |
|
| Background |
| De Greef E, Hoffman I, Smets F, Van Biervliet S, Bontems P, Hauser B, Paquot I, Alliet P, Arts W, Dewit O, De Vos M, Baert F, Bossuyt P, Rahier JF, Franchimont D, Vermeire S, Fontaine F, Louis E, Coche JC, Veereman G; IBD working group of BESPGHAN, BIRD. Paediatric Crohn Disease: Disease Activity and Growth in the BELCRO Cohort After 3 Years Follow-up. J Pediatr Gastroenterol Nutr. 2016 Aug;63(2):253-8. doi: 10.1097/MPG.0000000000001132. |
| 42154069 | Derived | Klomberg RCW, Griffiths AM, Aloi M, Kiparissi F, Lawrence S, Otley AR, Critch J, van der Feen C, Rodrigues A, Mack DR, Huynh HQ, Church PC, Rizopoulos D, Croft NM, de Ridder L, Walters TD; European Paediatric IBD Network for Safety, Efficicacy of Treatment and Quality Improvement of Care (PIBD-SETQuality); Canadian Children IBD Network (CIDsCaNN). A comparative analysis of corticosteroids and exclusive enteral nutrition induction therapy in children with small bowel Crohn's disease: results of two prospective cohorts. Eur J Pediatr. 2026 May 19;185(6):413. doi: 10.1007/s00431-026-07061-8. |
| 41807295 | Derived | Vuijk SA, Klomberg RCW, Schwerd T, Griffiths AM, Hussey S, Carroll MW, Malmborg P, Deb P, Wessels M, Mouratidou N, van Biervliet S, Friedt M, Minson S, Vrieling-Prince FHM, Croft NM, de Ridder L; PIBD-SETQuality Safety Registry Collaborative Group. Significant kidney impairment in pediatric inflammatory bowel disease and practice points for pediatric gastroenterologists. J Pediatr Gastroenterol Nutr. 2026 May;82(5):1251-1260. doi: 10.1002/jpn3.70391. Epub 2026 Mar 10. |
| 36480463 | Derived | Nugteren S, Simons-Oosterhuis Y, Menckeberg CL, Hulleman-van Haaften DH, Lindenbergh-Kortleve DJ, Samsom JN. Endogenous secretory leukocyte protease inhibitor inhibits microbial-induced monocyte activation. Eur J Immunol. 2023 Feb;53(2):e2249964. doi: 10.1002/eji.202249964. Epub 2022 Dec 22. |
| 32611739 | Derived | Aardoom MA, Kemos P, Tindemans I, Aloi M, Koletzko S, Levine A, Turner D, Veereman G, Neyt M, Russell RK, Walters TD, Ruemmele FM, Samsom JN, Croft NM, de Ridder L; PIBD-SETQuality consortium and PIBD-NET. International prospective observational study investigating the disease course and heterogeneity of paediatric-onset inflammatory bowel disease: the protocol of the PIBD-SETQuality inception cohort study. BMJ Open. 2020 Jul 1;10(7):e035538. doi: 10.1136/bmjopen-2019-035538. |
| D003092 | Colitis |
| D003108 | Colonic Diseases |