Pancreatic enzyme plus oral supplements for older adults at risk of malnutrition

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled trial tests whether adding pancrelipase (Zenpep®) to oral nutritional supplements improves postprandial absorption of amino acids, fatty acids, and glucose in hospitalized older adults at nutritional risk. Eligible participants are age 70 or older, hospitalized at the study site, have an NRS-2002 score of ≥3, and can eat orally; they are randomized to receive pancrelipase or matching placebo with an oral nutritional supplement. The primary pharmacodynamic outcomes are postprandial nutrient levels measured after administration, with safety and clinical parameters also recorded. The trial focuses on patients without diagnosed exocrine pancreatic insufficiency and excludes those with recent major gastrointestinal surgery, planned transplant or new dialysis, recent acute cardiovascular events, terminal conditions, or known hypersensitivity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Informed Consent as documented by signature
* Male or female 60 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

Where it's running

• Kantonsspital Aarau
  Aarau, Switzerland Recruiting

Study contacts

• Principal investigator: Philipp Schuetz, Prof. MD — Kantonsspital Aarau
• Study coordinator: Philipp Schuetz, Prof. MD
• Email: philipp.schuetz@ksa.ch
• Phone: +41 62 838 68 80

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.