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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT07171593
Eligibility Criteria:
Inclusion Criteria:
1. Patients with active Crohn's disease (CD) who visited the Sixth Affiliated Hospital of Sun Yat-sen University between July 2023 and December 2024;
2. Aged 18-50 years;
3. Complicated with sarcopenia;
4. Willing and able to tolerate oral exclusive enteral nutrition (EEN) therapy;
5. Signed informed consent and able to comply with the study procedures;
6. Colonic or ileocolonic type CD (SES-CD ≥6; if only terminal ileum is involved, SES-CD ≥4).
Exclusion Criteria:
1. Short bowel syndrome;
2. High-output jejunal fistula;
3. Severe stress or shock status;
4. Complete mechanical intestinal obstruction, acute gastrointestinal bleeding, or severe intra-abdominal infection;
5. Severe hepatic, renal, or cardiac diseases, or malignant tumors;
6. History of allergy or contraindication to Ensure or HMB;
7. Persistent severe vomiting or intractable diarrhea;
8. Congenital disorders of sugar or amino acid metabolism;
9. Underwent CD-related intestinal surgery or received biologic therapy within the past month, or received immunosuppressive/antibiotic therapy related to CD within 2 weeks prior to enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT07171593
Study Brief:
Protocol Section:
NCT07171593