PIBD-SETQuality: the Inception Cohort and Safety Registry

NCT03571373 | Recruiting

• 1 other identifier: PIBD-Net 2016-02
• Study Type: observational
• Target: 1,500
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• New biomarkers as classifiers of response or non-response to therapy

  Over a period of three years after inclusion of the last patient.

• Identification of patients with rare and serious complications

  Until the end of patients recruitment, for a period of 2 years.

Interventions

No intervention OTHER

No intervention due to the observational set-up of this study.

Eligibility Criteria

• Age: 0 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with paediatric-onset IBD (either Crohn's disease, ulcerative colitis or IBD-unclassified).

You may qualify if:

• 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:
• Diagnosis is based on history, physical examination, laboratory, endoscopic, radiological and histological features according to the revised Porto criteria (1)
• Informed consent of patient (if indicated) and parents has been obtained
• Concerning the patients of whom biological specimens will be included: patients have not started IBD treatment yet
• 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.

You may not qualify if:

• Inability to read and understand the patient and family information sheets (for example insufficient knowledge of national language, where no health advocate or family member is available to translate and ensure full understanding of the study)
• Informed consent of patient or parents has not been obtained when required
• Patients on similar treatments as for IBD but for other conditions, or known with conditions directly affecting the IBD (e.g. immunodeficiency or major gastrointestinal resections)

Sponsors & Collaborators

• PIBD-Net: lead
• European Commission: collaborator

Study Sites (2)

Erasmus MC - Sophia Children's Hospital

Rotterdam, 3015GD, Netherlands

RECRUITING

Royal Hospital London

London, United Kingdom

RECRUITING

Related Publications (4)

• 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.

  PMID: 21051046 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.

  PMID: 26835906 BACKGROUND

• 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.

  PMID: 36480463 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.

  PMID: 32611739 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Lissy de Ridder, MD, PhD

  Erasmus MC-Sophia Children's Hospital

  PRINCIPAL INVESTIGATOR

• Nicholas Croft, MD, PhD

  Barts and the London School of Medicine, Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frank Ruemmele, MD, PhD

CONTACT

frank.ruemmele@nck.aphp.fr

Lissy de Ridder, MD, PhD

CONTACT

l.deridder@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: June 27, 2018
• Study Start: January 3, 2017
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); NL (1)