Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's): Implementation and Feasibility
Not applicable · Testing Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool and Standard Crohn's… · 1 site · Massachusetts General Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool (a behavioral program) and Standard Crohn's Disease Education (a behavioral program) to see if it can prevent disease or complications. Condition(s) listed: Inflammatory Bowel Diseases, Crohn Disease and Crohn Colitis.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 14 and older
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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
Plus 2 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 80 participants are expected to take part.
- Start date: 2025-10-03.
- Main results expected around 2027-11 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Total enrollment (n) at 1.5 years and retention rate (%) at study conclusion (1.5 years and time of study completion)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Diseases; Crohn Disease; Crohn Colitis; Crohn's Ileocolitis; Crohn's Gastritis; Crohn's Jejunitis; Crohn's Duodenitis; Crohn's Esophagitis |
| Lead sponsor | Massachusetts General Hospital |
| Collaborators | American College of Gastroenterology; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Enrollment | 80 (estimated) |
| Start date | 2025-10-03 |
| Primary completion (est.) | 2027-11 |
| First posted | 2022-04-18 |
| Last updated | 2026-01-30 |
| Official title | Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's): Implementation and Feasibility |
| ClinicalTrials.gov ID | NCT05332639 |
Interventions
- Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool (Behavioral)
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 us… - Standard Crohn's Disease Education (Behavioral)
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…
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital | Boston, Massachusetts | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.