At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- No intervention (other)
- How long the study runs
- Study runs about 167 months (dates as stated)
- About the drug or intervention
- No intervention — other: No intervention due to the observational set-up of this study.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, called PIBD-SETQuality, looks at children and teenagers under 19 with inflammatory bowel disease (IBD), which includes Crohn's disease and ulcerative colitis. It has two parts: one follows children newly diagnosed with IBD, and the other collects reports of children with IBD who develop certain health problems (complications). The sponsor is Erasmus Medical Center.
Who can take part
- Newly diagnosed children under 18 with a likely or confirmed diagnosis of IBD, where the diagnosis is made or confirmed within 2 months of joining
- The diagnosis is based on checks such as medical history, examination, blood tests, camera tests (endoscopy), scans and tissue samples, following agreed guidelines
- All results from these diagnostic checks are available to add to the study database
- The patient (where needed) and parents give informed consent
- Children whose samples will be stored must not have started IBD treatment yet
- For the safety registry part: any child with IBD under 19 who has a complication from the agreed safety monitoring list can be reported, with no identifying details needed at first
Who may not be able to
- People who cannot read and understand the patient and family information sheets (for example, due to language, if no translator is available)
- Informed consent from the patient or parents has not been given when required
- Children on similar treatments to IBD treatment but for other conditions, or with conditions that directly affect the IBD (such as a weakened immune system or major bowel surgery)
- The safety registry part has no exclusion criteria
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 0 Years to 19 Years
- Who
- All
- Number of participants
- 1,500
- Started
- 2017-01-03
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for inflammatory bowel diseases
- • Clinical study - 1,500 participants
- • 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
Who can take part?
- • Ages 0 Years to 19 Years
- • Diagnosed with inflammatory bowel diseases
Where?
- • London - Royal Hospital London
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 0 Years - 19 Years
- Who can join: All genders
What the study is looking for
- ✓Inclusion Criteria Inception cohort:
- ✓Diagnosis is based on history, physical examination, laboratory, endoscopic, radiological and histological features...
- ✓Diagnosis has been made or is confirmed within 2 months of inclusion
- ✓Data on all diagnostic procedures are available for inclusion in the database
- ✓agreement to take part of patient (if indicated) and parents has been obtained
See the full criteria
Where Is This Study? (1 UK site)
Royal Hospital London
London, United Kingdom
How to Get in Touch
Lissy de Ridder, Professor, MD
Sponsor contactCONTACT
Nick M. Croft, Professor, MD
Sponsor contactCONTACT