The PREDICT-CD study aims to validate a risk score for the development of Crohn's disease, based on serological biomarkers and lifestyle-related factors. Given that having a family member with the disease is the strongest known risk factor, the target population will consist of first-degree relatives (aged 16 to 35) of individuals diagnosed with Crohn's disease.
This study will be conducted within Work Package 3 (WP3) of the INTERCEPT project, a consortium funded by the Innovative Health Initiative (IHI). The research will take place across 28 centres in seven countries: Portugal, Spain, France, Italy, the Netherlands, Sweden, and Poland.
To achieve the study objectives, individuals with Crohn's disease (referred to as patients) will be invited to participate and to engage their eligible first-degree relatives. At the baseline visit, the patient's physician will complete a clinical questionnaire covering disease history, treatments, and previous interventions.
At the same time, first-degree relatives (parents, siblings, or children) will donate a blood sample for serum isolation and, optionally, a whole blood and stool sample. They will also complete a questionnaire regarding their health status, habits, and preferences. Follow-up questionnaires will be administered every six months to monitor the onset of symptoms or behavioural changes.
Male or female participants, between 16 and 35 years old
FDR (parent, full-siblings or offspring) from a patient with an established diagnosis of CD
Participants able to understand the information provided to them and to give written informed assent or consent for the study.
Prior diagnosis of IBD
Any legal or medical condition that limits the information and participation in the study
Inability to verify CD diagnosis in the proband
Participants unwilling or unable to provide informed written consent
The first-degree relative without a previous diagnosis of Inflammatory Bowel Disease
Cohort
Prospective
Not listed
Assess the performance of a risk model for at-risk population for CD
The model will integrate measures of predefined serum biomarkers of at-risk population (first degree relatives of CD patients) with clinical and lifestyle factors. The performance can than be assessed by the risk prediction of participants which are then diagnosed with CD.
Prevalence of risk factors in FDRs developing IBD
Evaluation of 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 in FDRs developing IBD during the study through semestral questionnaires
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This trial is not recruiting at the moment. You can still explore other options:
