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 @ 3:16 AM
Ignite Modification Date:
2025-12-25 @ 3:16 AM
NCT ID:
NCT06826105
Eligibility Criteria:
Inclusion Criteria:
* Informed Consent as documented by signature
* Male or female 70 years of age or older
* Hospitalized at site
* Nutrition Risk Screening 2002 (NRS-2002) ≥ 3
* eGFR ≥ 30 mL/min/1.73 m2 (EPI-CKD) based on medical history (no older than 6 months)
* Ability to eat orally
Exclusion Criteria:
* Patients with acute cardiovascular event ≤ 2 days
* Patients with terminal conditions
* Patients diagnosed with pancreatic exocrine insufficiency (EPI) treated with pancreatic enzyme replacement therapy (PERT)
* Patients having a planned transplant or new-onset dialysis in the next 6 months.
* Patients having a colectomy, resection of the small intestine or cholecystectomy
* Known hypersensitivity to any of the substances or excipients of the ONS or the medicinal product
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT06826105
Study Brief:
Protocol Section:
NCT06826105