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 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT05719402
Eligibility Criteria:
Inclusion Criteria:
* \> 18 years
* established diagnosis since at least 3 months requiring colonoscopy, US and histologic evaluation of tissue biopsies according to ECCO international guidelines 3-5
* 50 CD ileo-colonic patients, 25 in endoscopic activity (as defined by a SES-CD \> 2), 25 in endoscopic remission (as defined by a SES-CD \< 2), independently from treatment;
* 50 UC patients, 25 in endoscopic activity (as defined by a Mayo endoscopic score \> 2), 25 in endoscopic remission (as defined by a Mayo endoscopic score \< 2), independently from treatment.
Exclusion Criteria:
* Patients with inflammation restricted to the rectum (≤ 15 cm from the anal verge);
* UC patients without involvement of sigmoid colon or inability to reach the sigmoid colon by CS;
* CD patients without ileal involvement or inability to reach the ileum by CS;
* Patients with severe UC (defined as a Mayo global score \> 12, requiring hospitalization);
* Pregnancy;
* Previous intestinal surgery;
* Concomitant intestinal infection (e.g. Clostridium difficile);
* Cirrhosis or intra-abdominal ascites.
* Patients not able to comply with any study procedure;
* Patients not able to understand and give informed consent form;
* Patients with any contraindication to any study procedure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05719402
Study Brief:
Protocol Section:
NCT05719402