Clinical trial NCT05332639: Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's): Implementation and Feasibility
Official title: Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's): Implementation and Feasibility
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Crohn Colitis
Crohn's Ileocolitis
Crohn's Gastritis
Crohn's Jejunitis
Crohn's Duodenitis
Crohn's Esophagitis
Keywords: Crohn's disease
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: American College of Gastroenterology
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-04-18
Enrollment: 80
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


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

Primary outcomes:
measure: Total enrollment (n) at 1.5 years and retention rate (%) at study conclusion
timeFrame: 1.5 years and time of study completion
Secondary outcomes:
measure: Motivation to change smoking behavior
timeFrame: 8 weeks and 6 months
measure: Motivation to change diet
timeFrame: 8 weeks and 6 months
measure: Motivation to change physical activity
timeFrame: 8 weeks and 6 months
measure: Change in physical activity
timeFrame: 8 weeks and 6 months
measure: Change in fruit intake
timeFrame: 8 weeks and 6 months
measure: Change in vegetable intake
timeFrame: 8 weeks and 6 months
measure: Change in processed meat intake
timeFrame: 8 weeks and 6 months
measure: Change in fiber intake
timeFrame: 8 weeks and 6 months
measure: Change in added sugar intake
timeFrame: 8 weeks and 6 months
measure: Change in smoking behaviors
timeFrame: 8 weeks and 6 months
measure: Change in C-reactive protein (CRP; mg/L)
timeFrame: 8 weeks and 6 months
measure: Change in fecal calprotectin (mcg/g)
timeFrame: 8 weeks and 6 months
measure: Change in seropositivity for antimicrobial biomarkers
timeFrame: 8 weeks and 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Emily Lopes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Colditz GA, Dart H. Commentary: 20 years online with "Your Disease Risk". Cancer Causes Control. 2021 Jan;32(1):5-11. doi: 10.1007/s10552-020-01356-3. Epub 2020 Oct 17.