Inflammatory Bowel DiseasesNCT05332639
Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's): Implementation and Feasibility
A study testing Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool and Standard Crohn's Disease Education in people with Inflammatory Bowel Diseases and Crohn Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Crohn Colitis
- What is being tested?
- Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool and Standard Crohn's Disease Education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Emily W. Lopes, MD, 617-726-5560, mghprecrohns@mgb.org
Emily W. Lopes, MD
About this study
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.
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease, Crohn Colitis, Crohn's Ileocolitis, Crohn's Gastritis, Crohn's Jejunitis
- Being tested
- Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool, Standard Crohn's Disease Education
- Keywords
- Crohn's disease
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) toolBehavioural
Also called Intervention Arm
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.
Standard Crohn's Disease EducationBehavioural
Also called Comparator Arm
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool Receives: Behavioral: Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool |
| Comparator arm | Active comparator | Standard Crohn's Disease Education Receives: Behavioral: Standard Crohn's Disease Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total enrollment (n) at 1.5 years and retention rate (%) at study conclusion
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.
Measured: 1.5 years and time of study completion
Secondary outcomes (13)
Motivation to change smoking behavior
We will measure change in contemplation ladder scores for motivation to change smoking behavior (yes/no for achieving a 1-point increase)
Measured: 8 weeks and 6 months
Motivation to change diet
We will measure change in contemplation ladder scores for motivation to change diet (yes/no for achieving a 1-point increase)
Measured: 8 weeks and 6 months
Motivation to change physical activity
We will measure change in contemplation ladder scores for motivation to change physical activity (yes/no for achieving a 1-point increase)
Measured: 8 weeks and 6 months
Change in physical activity
We will measure change in physical activity (MET-hours/week)
Measured: 8 weeks and 6 months
Change in fruit intake
We will measure change in fruit intake (servings/day)
Measured: 8 weeks and 6 months
Change in vegetable intake
We will measure change in vegetable intake (servings/day)
Measured: 8 weeks and 6 months
Change in processed meat intake
We will measure change in processed meat intake (servings/day)
Measured: 8 weeks and 6 months
Change in fiber intake
We will measure change in fiber intake (grams/day)
Measured: 8 weeks and 6 months
Change in added sugar intake
We will measure change in added sugar intake (grams/day)
Measured: 8 weeks and 6 months
Change in smoking behaviors
We will measure change in smoking behaviors including current smoking vs non-smoking and cigarettes/day
Measured: 8 weeks and 6 months
Change in C-reactive protein (CRP; mg/L)
We will measure change in CRP (mg/L)
Measured: 8 weeks and 6 months
Change in fecal calprotectin (mcg/g)
We will measure change in fecal calprotectin (mcg/g)
Measured: 8 weeks and 6 months
Change in seropositivity for antimicrobial biomarkers
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.
Measured: 8 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start3 Oct 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Gastroenterology, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Emily R. Lopes, MD, MPH, Massachusetts General Hospital
- Investigators
- Emily Lopes, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332639
- Sponsor's protocol ID
- 2022p000905
- Other IDs
- 1K23DK136977-01
- Status last verified
- Jan 2026
- First submitted
- 28 Mar 2022
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Aggregate-level results of from this study will be reported on clinicaltrials.gov. De-identified individual-level data will be uploaded to a separate controlled access repository and can be available upon reasonable request and per controlled access repository standard terms and procedures.
Publications
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.
PubMed 33068181
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's): Implementation and Feasibility
- ClinicalTrials.gov ID
- NCT05332639
- Acronym / sponsor ID
- 2022p000905
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease, Crohn Colitis, Crohn's Ileocolitis, Crohn's Gastritis, Crohn's Jejunitis
- Keywords
- Crohn's disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- American College of Gastroenterology, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) toolPersonalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool |
| Comparator arm | Active comparator | Behavioral: Standard Crohn's Disease EducationStandard Crohn's Disease Education |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) toolAlso: Intervention ArmWe 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. | Behavioural | Intervention Arm |
| Standard Crohn's Disease EducationAlso: Comparator ArmThe 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. | Behavioural | Comparator arm |
Primary outcome
Total enrollment (n) at 1.5 years and retention rate (%) at study conclusion
Time frame: 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.
13 secondary outcomes
Motivation to change smoking behavior
Time frame: 8 weeks and 6 months
Motivation to change diet
Time frame: 8 weeks and 6 months
Motivation to change physical activity
Time frame: 8 weeks and 6 months
Change in physical activity
Time frame: 8 weeks and 6 months
Change in fruit intake
Time frame: 8 weeks and 6 months
Change in vegetable intake
Time frame: 8 weeks and 6 months
Change in processed meat intake
Time frame: 8 weeks and 6 months
Change in fiber intake
Time frame: 8 weeks and 6 months
Change in added sugar intake
Time frame: 8 weeks and 6 months
Change in smoking behaviors
Time frame: 8 weeks and 6 months
Change in C-reactive protein (CRP; mg/L)
Time frame: 8 weeks and 6 months
Change in fecal calprotectin (mcg/g)
Time frame: 8 weeks and 6 months
Change in seropositivity for antimicrobial biomarkers
Time frame: 8 weeks and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Background: PubMed 33068181Colditz 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.
- Your Disease RiskLink provided by the sponsor.
- NIH Reporter Prevention of Crohns Disease in High-Risk IndividualsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Aggregate-level results of from this study will be reported on clinicaltrials.gov. De-identified individual-level data will be uploaded to a separate controlled access repository and can be available upon reasonable request and per controlled access repository standard terms and procedures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily Lopes, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool and Standard Crohn's Disease Education in people with Inflammatory Bowel Diseases and Crohn Disease, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily W Lopes, MD (617-726-5560, mghprecrohns@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total enrollment (n) at 1.5 years and retention rate (%) at study conclusion (time frame: 1.5 years and time of study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05332639, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.