Pancrelipase With Nutritional Supplement in Patients at Risk of Malnutrition (EFFORT-ENZO)
Effect of Low Dose Pancrelipase With an Oral Nutritional Supplement to Improve Nutrient Bioavailability in Patients at Increased Risk of Malnutrition
Philipp Schuetz
20 participants
Sep 22, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria6
- 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
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Interventions
two capsules (each containing 15000 USP units of lipase) together with nutritional supplements
two capsules (containing placebo) together with nutritional supplements
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06826105