Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT05211518
Eligibility 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).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
38 Years
Study:
NCT05211518
Study Brief:
Protocol Section:
NCT05211518