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NCT Number: NCT05332639

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

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.

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Key information

Conditions

Inflammatory Bowel Diseases Crohn Colitis Crohn Disease Crohn's Duodenitis Crohn's Esophagitis Crohn's Gastritis Crohn's Ileocolitis Crohn's Jejunitis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Emily W. Lopes, MD

CONTACT

[email protected]

617-726-5560

Emily W. Lopes, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Other names: Intervention Arm

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 PRE-Crohn's tool as well.

Other names: Comparator Arm

Primary outcomes

  1. 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.

Secondary outcomes

  1. Motivation to change smoking behavior

    Time frame: 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)

  2. Motivation to change diet

    Time frame: 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)

  3. Motivation to change physical activity

    Time frame: 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)

  4. Change in physical activity

    Time frame: 8 weeks and 6 months

    We will measure change in physical activity (MET-hours/week)

  5. Change in fruit intake

    Time frame: 8 weeks and 6 months

    We will measure change in fruit intake (servings/day)

  6. Change in vegetable intake

    Time frame: 8 weeks and 6 months

    We will measure change in vegetable intake (servings/day)

  7. Change in processed meat intake

    Time frame: 8 weeks and 6 months

    We will measure change in processed meat intake (servings/day)

  8. Change in fiber intake

    Time frame: 8 weeks and 6 months

    We will measure change in fiber intake (grams/day)

  9. Change in added sugar intake

    Time frame: 8 weeks and 6 months

    We will measure change in added sugar intake (grams/day)

  10. Change in smoking behaviors

    Time frame: 8 weeks and 6 months

    We will measure change in smoking behaviors including current smoking vs non-smoking and cigarettes/day

  11. Change in C-reactive protein (CRP; mg/L)

    Time frame: 8 weeks and 6 months

    We will measure change in CRP (mg/L)

  12. Change in fecal calprotectin (mcg/g)

    Time frame: 8 weeks and 6 months

    We will measure change in fecal calprotectin (mcg/g)

  13. Change in seropositivity for antimicrobial biomarkers

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emily W Lopes, MD

CONTACT

[email protected]

617-726-5560

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • American College of Gastroenterology
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 18, 2022
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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