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Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's): Implementation and Feasibility

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
14 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a website that gives people a personal estimate of their risk for Crohn’s disease. It compares the website with standard Crohn’s education to see if it changes health habits and early signs of disease risk in the body. It is for people over age 14 who do not have inflammatory bowel disease (IBD) but have a parent, sibling, or child with IBD.

The aim of this study is to develop and assess the feasibility and effect of a web-based, personalized risk-estimation for Crohn's disease (PRE-Crohn's) tool on behaviors and biomarkers associated with risk for Crohn's disease in unaffected first-degree relatives of patients with inflammatory bowel disease. We hypothesize that personalized risk disclosure via the PRE-Crohn's educational tool is both feasible and successful in modifying behaviors associated with Crohn's disease risk and normalizing pre-clinical disease biomarkers when compared to standard Crohn's disease education. Broadly, completion of this project will also help elucidate the role of lifestyle and dietary factors in pre-clinical Crohn's disease development in high-risk individuals, and provide novel insight into potential strategies for disease prevention in this population.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Can understand the study and agree to take part.
  • Can and will attend all study visits and follow study steps.
  • Can understand and fill out study forms.
  • Have a parent, sibling, or child with IBD, a group of diseases that cause swelling in the digestive tract. This includes Crohn’s disease, ulcerative colitis, or IBD whose type is unclear.
  • Are older than 14.

Who can't join

  • Cannot understand the study or agree to take part.
  • Cannot attend all study visits or follow study steps.
  • Cannot understand or fill out study forms.
  • Already have IBD, including Crohn’s disease, ulcerative colitis, or IBD whose type is unclear.
  • Have signs or symptoms of IBD, based on a study symptom checklist.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Ability to give informed consent * Ability and willingness to comply with all patient visits and study-related procedures * Ability to understand and complete study questionnaires * Must have at least one first-degree relative with inflammatory bowel disease (Crohn's disease, ulcerative colitis, or indeterminate colitis/IBD unclassified) * Individuals greater than 14 years of age Exclusion Criteria: * Inability to provide informed consent * Inability to comply with all patient visits and study-related procedures * Inability to understand or complete study questionnaires * Patients with existing diagnoses of inflammatory bowel disease (ulcerative colitis, Crohn's disease, or indeterminate colitis/IBD unclassified) * Evidence of clinical signs or symptoms of inflammatory bowel disease, identified by a modified version of the Harvey-Bradshaw Index for CD activity

Study sites (1)

MA