Crohn's disease bowel inflammation
Conditions
Interventions
Analyses will be performed on all individual serum samples in order to calculate a risk score for developing Crohn's disease. This score provides insight into the likelihood that someone will develop
Sponsors
GLSMED Learnng Health SA; Hospital da Luz Learning Health
Eligibility
Age
16 Years to 99 Years
Inclusion criteria
Inclusion criteria: Male or female participants, between 16 and 35 years old.First-degree relative (FDR) (parent, full-sibling or offspring) from a patient with an established diagnosis of Crohn's disease Participants able to understand the information provided to them and to give informed consent or assent for the study.Participants must own a smartphone (for wearable sub-study only).
Exclusion criteria
Exclusion criteria: Prior diagnosis of IBD Any legal or medical condition that limit the information and participation in the study Inability to verify CD diagnosis in the proband Participants unwilling or unable to provide informed written consent Participants unwilling or unable to donate a blood sampleSpecific exclusion criteria apply only to the wearable sub-study:Patients with pacemakers or defibrillators The use of medications known to affect autonomic nervous system function, including but not limited to beta-blockers and benzodiazepines Serious co-morbidity including immunodeficiency, recent myocardial infarction or stroke (in the past 3 months), renal or hepatic failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To prospectively validate a predictive model for Crohn's Disease development in a population at-risk for Crohn's Disease development, integrating previously identified serum biomarkers (serological risk score) and additional relevant clinical risk factors. | — |
Secondary
| Measure | Time frame |
|---|---|
| To identify First degree relatives (FDR's) with a high serological risk score for Crohn's Disease development who may be candidates to enter a disease-prevention trial. To describe the characteristics of FDRs who develop Inflammatory Bowel Disease during the study period, including time until diagnosis and disease characteristics (e.g., phenotype, behaviour, disease severity), in comparison to their proband(s) To longitudinally assess the presence and prevalence of clinical symptoms in FDRs To assess the presence, prevalence of risk factors for CD development among FDRs, including early life risk factors, dietary and nutritional patterns, fatigue, stress, and physical exercise levels, smoking history and exposure to smoking, medical and surgical history, and medication history To identify the development of other Immume-Mediated Inflammatory Diseases during follow-up To describe the association between the above-mentioned risk factors and the biomarker(s) | — |
Countries
France, Italy, Netherlands, Poland, Portugal, Spain, Sweden
Contacts
Public ContactG.R.A.M. D'Haens
Amsterdam UMC
Outcome results
None listed