Crohn Colitis, Crohn Disease, Crohn's Duodenitis, Crohn's Esophagitis, Crohn's Gastritis, Crohn's Ileocolitis, Crohn's Jejunitis, Inflammatory Bowel Diseases
Conditions
Keywords
Crohn's disease
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.
Interventions
BEHAVIORALPersonalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool
We will develop a web-based, personalized risk estimation for CD (PRE-Crohn's) tool to quantitate participants' relative risk (RR) and lifetime risk of CD based on known risk factors for disease. We will consider the following risk factors for Crohn's disease: body mass index (BMI); smoking history; NSAID use; intake of fruit, fiber, and added sugar; oral contraceptive use (females); antibiotic use; breast-feeding; pets in home; and anti-microbial biomarker positivity. This tool will also display a participants' personalized summary of their risk factors for CD as well as educational tools for modifying these factors. Construction of this tool is based on the Your Disease Risk tool developed by the Siteman Cancer Center at Washington University in St. Louis School of Medicine. The interventional group will also receive standard education about Crohn's disease (comparison group intervention) via the web-based tool.
BEHAVIORALStandard Crohn's Disease Education
The comparison group will receive standard education about Crohn's disease, which will include information regarding the prevalence of disease, clinical presentation including signs and symptoms of disease, and treatment options including available medications. Upon completion of the study, the comparator arm will be given the option of receiving their personalized risk of Crohn's disease with the PRE-Crohn's tool as well.
Sponsors
Massachusetts General Hospital
American College of Gastroenterology
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total enrollment (n) at 1.5 years and retention rate (%) at study conclusion | 1.5 years and time of study completion | The total enrollment at 1.5 years and the retention rate recorded at the conclusion of the study will be measured based on completion of the 6-month survey. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motivation to change smoking behavior | 8 weeks and 6 months | We will measure change in contemplation ladder scores for motivation to change smoking behavior (yes/no for achieving a 1-point increase) |
| Motivation to change diet | 8 weeks and 6 months | We will measure change in contemplation ladder scores for motivation to change diet (yes/no for achieving a 1-point increase) |
| Motivation to change physical activity | 8 weeks and 6 months | We will measure change in contemplation ladder scores for motivation to change physical activity (yes/no for achieving a 1-point increase) |
| Change in physical activity | 8 weeks and 6 months | We will measure change in physical activity (MET-hours/week) |
| Change in fruit intake | 8 weeks and 6 months | We will measure change in fruit intake (servings/day) |
| Change in vegetable intake | 8 weeks and 6 months | We will measure change in vegetable intake (servings/day) |
| Change in processed meat intake | 8 weeks and 6 months | We will measure change in processed meat intake (servings/day) |
| Change in fiber intake | 8 weeks and 6 months | We will measure change in fiber intake (grams/day) |
| Change in added sugar intake | 8 weeks and 6 months | We will measure change in added sugar intake (grams/day) |
| Change in smoking behaviors | 8 weeks and 6 months | We will measure change in smoking behaviors including current smoking vs non-smoking and cigarettes/day |
| Change in C-reactive protein (CRP; mg/L) | 8 weeks and 6 months | We will measure change in CRP (mg/L) |
| Change in fecal calprotectin (mcg/g) | 8 weeks and 6 months | We will measure change in fecal calprotectin (mcg/g) |
| Change in seropositivity for antimicrobial biomarkers | 8 weeks and 6 months | We will measure several Crohn's disease associated antimicrobial biomarkers including ASCA IgA and IgG, anti-OmpC, anti-CBir1, anti-A4-Fla2 and anti-FlaX will be assayed using the PROMETHEUS® IBD sgi Diagnostic® panel. Positivity for each of these components are defined as follows: ASCA IgA \> 9.2 EU/mL; ASCA IgG \> 11.9 EU/mL; anti-OmpC \> 11.3 EU/mL; anti-CBir1 \> 35.4 EU/mL; anti-A4-Fla2 \> 32.4 EU/mL and anti-FlaX \> 36.0 EU/mL. Total biomarker positivity (secondary outcome) will be defined as the presence of 1 or more positive individual biomarkers above. We will then assess for change in total biomarker positivity at 8 weeks and 6 months compared to baseline. |
Countries
United States
Contacts
CONTACTEmily W Lopes, MD
PRINCIPAL_INVESTIGATOREmily Lopes, MD
Massachusetts General Hospital
Outcome results
None listed