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 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT05611866
Eligibility Criteria:
Inclusion Criteria:
* \>18 years of age;
* Patients with CD history ≥ 3-month duration;
* Patients with no or mild-to-moderate symptoms defined as Harvey Bradshaw Index (HBI) \< 16 ;
* Patients with positive total E.coli antibodies (AEcAb)
Exclusion Criteria:
* Pregnancy;
* New biological treatment or steroids use within 4 weeks;
* Current Colorectal tumor;
* Active gastrointestinal bleeding;
* Having ulcerative colitis;
* Having colectomy or partial colectomy (less than ileo-transverse colonic anastomosis);
* Having colonic or small bowel stoma;
* Active perianal lesions;
* Receiving antibiotics within 4 weeks;
* Presenting psychological or linguistic incapability to sign the informed consent
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05611866
Study Brief:
Protocol Section:
NCT05611866