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 @ 1:09 PM
Ignite Modification Date:
2025-12-24 @ 1:09 PM
NCT ID:
NCT02897661
Eligibility Criteria:
Inclusion Criteria:
1. patients aged 18 to 65 years with active CD, as defined by Harvey-Bradshaw Index (HBI) score \>4;
2. patients accompanied with malnutrition as assessed by Nutritional Risk Screening 2002 (NRS2002) score ≥ 3 or Patient-Generated Subjective Global Assessment (PG-SGA) score ≥ 4;
3. patients with high compliance.
Exclusion Criteria:
1. accompanying with contraindications of enteral nutrition (EN) such as ileus, active gastrointestinal bleeding and shock;
2. severe comorbidities (e.g., Clostridium difficile infection, diabetes, cancer, cardiopulmonary failure and severe liver and kidney diseases;
3. parenteral infection such as urinary infection, pneumonia, etc;
4. steroids or biologicals use within 6 week;
5. intestinal fibrotic stenosis;
6. patients who are pregnant or going to be pregnant;
7. patients with mental disorders.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02897661
Study Brief:
Protocol Section:
NCT02897661