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

Massachusetts General Hospital · with American College of Gastroenterology, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NCT05332639

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 14+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
80
US sites recruiting
1
Study start
October 3, 2025
Record last updated
January 30, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool; Standard Crohn's Disease Education

Conditions: Inflammatory Bowel Diseases; Crohn Disease; Crohn Colitis; Crohn's Ileocolitis; Crohn's Gastritis; Crohn's Jejunitis; Crohn's Duodenitis; Crohn's Esophagitis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Massachusetts General Hospital

    Boston, MA 02114

    Site contact: Emily W. Lopes, MD · 617-726-5560 · mghprecrohns@mgb.org

Study contacts (from the official record)

  • Emily W Lopes, MD · 617-726-5560 · mghprecrohns@mgb.org
All healthy volunteers studies in Massachusetts →
Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's):… (NCT05332639) | Bored Studies