Preventing Crohn's disease in at-risk individuals
Preventing IBD Onset in Individuals At Risk
This study is testing if a special diet can help prevent Crohn's disease in healthy people under 39 who have a family history of the condition or other risk factors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 6 Years to 38 Years |
| Sex | All |
| Sponsor | Shaare Zedek Medical Center Academic / other |
| Locations | 1 site (Jerusalem) |
| Trial ID | NCT05211518 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of the Tasty&Healthy dietary intervention in reducing the risk of developing Crohn's disease (CD) among first-degree relatives of CD patients. It employs a crossover randomized controlled design to assess changes in the GEM Risk Score (GRS) and other biological parameters associated with CD onset. Participants will be clinically healthy individuals under 39 years of age with elevated faecal calprotectin levels or other risk factors for CD. The study aims to determine if dietary modifications can positively influence gut health and reduce inflammation.
Who should consider this trial
Good fit: Ideal candidates are clinically healthy first-degree relatives of Crohn's disease patients who are under 39 years old and have elevated faecal calprotectin levels or other risk factors.
Not a fit: Patients with overt ulcerations in the ileum or colon or those already diagnosed with Crohn's disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly lower the risk of developing Crohn's disease in high-risk individuals.
How similar studies have performed: Previous studies have shown success with dietary interventions in managing Crohn's disease, suggesting potential for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * Clinically healthy subjects (i.e. lack of symptoms that may suggest IBD) who are First degree relatives of someone with CD with a high faecal calprotectin (FC)\>70μg/g or subjects who have a risk factor for example elevated GRS. Where available LMR will also be assessed to identify subjects ranked as top 100 at risk of CD. * Younger than 39 years of age, in order to maximize future risk of developing CD. * No overt ulcerations (other than aphthous ulcerations) in the ileum or colon. Some degree of inflammation may be seen in these high-risk subjects with increased risk parameters and this does not necessarily prompt the diagnosis of CD. Moreover, in this proof of concept study we would like to have those with the highest risk (hence some degree of initial inflammation) but without macroscopic inflammation that clearly is associated with the diagnosis of CD. Patency capsule and VCE procedure will be performed if the subjects calprotectin levels are \>70μg/g. Exclusion Criteria: * Ulcerative colitis (UC) or IBD-unclassified (IBDU) diagnosis * The use of antibiotics in the preceding month * Prior intestinal resection * Pregnancy (and up until six months after giving birth) * Celiac disease or Diabetes * Weight loss or weight gain by more than 20% body weight in the last 3 months * Extraintestinal manifestations (Arthritis/arthralgia, iritis/uveitis, skin/mouth lesions, peri-anal disease, Other fistula). * Underweight (children \<3th BMI percentile, adult above the age of 18 years: BMI\<18.5 kg/m2).
Where this trial is running
Jerusalem
- Shaare Zedek Medical Center — Jerusalem, Israel (Recruiting)
Study contacts
- Principal investigator: Dan Turner, Prof — Saare Zedek Medical Center
- Study coordinator: Gili Focht, Study Director
- Email: gilif@szmc.org.il
- Phone: 972-25645028
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.