Pancrelipase With Nutritional Supplement in Patients at Risk of Malnutrition (EFFORT-ENZO)
This study investigates if pancreatic enzymes in combination with oral nutritional supplement can improve nutrient bioavailability in older people with malnutrition or at risk of malnutrition.
| Condition(s) | Malnutrition |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This study investigates if pancreatic enzymes in combination with oral nutritional supplement can improve nutrient bioavailability in older people with malnutrition or at risk of malnutrition. |
| Who can participate | 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 |
| Ages | 70 Years |
| Sex | All |
| Lead sponsor | Philipp Schuetz |
| Locations | Aarau, Switzerland |
| Start date | 2025-09-22 |
| NCT ID | NCT06826105 |
| Official listing | https://clinicaltrials.gov/study/NCT06826105 |