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:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-24 @ 4:36 PM
NCT ID:
NCT04596566
Eligibility Criteria:
Inclusion Criteria:
* (a)≥18 years;
* (b)diagnosis of mild-to-moderate luminal ileal, ileo-colonic or colonic CD
* (c) active disease with Harvey Bradshaw Index (HBI) \<16 at time of recruitment;
* (d) for active symptomatic patients (HBI \> 5 to \<16) evidence of endoscopic disease activity within six months of enrolment (presence of ulceration ≥5mm ) and for active asymptomatic patients (HBI \<5) sonographic findings of intestinal inflammation ≥3mm of bowel wall thickening)
* (e) biomarker evidence of inflammation fecal calprotectin at enrolment (FCP
* 250microg/g).
* (f) \< OR = 1 small bowel resection,
* (g) ability to provide informed consent
Exclusion Criteria:
* HBI \>16 at time of recruitment;
* (b) fecal calprotectin \< 250 microg/mg within 1 month prior to study enrollment;
* (c) patients with upper GI tract CD;
* (d) evidence of perianal or fistulizing disease; (
* e) \>1 bowel surgery;
* (f) significant chronic disorders such as cardiac disease, renal failure, active pulmonary disease (these factors may influence dietary intake),
* (g) any psychiatric or neurocognitive comorbidity that would limit ability to follow an CD-TDI
* (h) laxative or antibiotics in the past 3 months and
* (i) presence of ostomy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04596566
Study Brief:
Protocol Section:
NCT04596566