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 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT02056418
Eligibility Criteria:
Inclusion Criteria:
1. Patients should be in the age range of 18 - 75 years;
2. Patients should have clinical, imaging, endoscopic and histological diagnosis of CD based on WHO criteria
3. Patients should have a CDAI score of more than 150 and have a CRP level of more than 10mg/L at enrollment;
4. Patients will not be excluded if they have received 5-ASA(Aminosalicylic acid) or immunomodulator for \>8 weeks and the dose is stable
5. Informed consent
Exclusion Criteria:
1. Patients who can't tolerate enteral nutrition because of complications, such as complete intestinal obstruction, gastrointestinal perforation or bleeding etc.
2. Patients who receive corticosteroids or enteral nutrition or prebiotics /probiotics/synbiotics/antibiotic treatment in the previous 4 weeks.
3. Patients who accompanied extra-intestinal manifestations, serve complications, and active perianal disease and need other drug therapies.
4. Patients who had ostomy or colectomy or subtotal colectomy
5. Patients with end-stage disease or is expected likely to die during the study
6. Patients are participating in other clinical trials or participated within 6 months prior to this study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02056418
Study Brief:
Protocol Section:
NCT02056418