Pancreatic enzyme plus oral supplements for older adults at risk of malnutrition
Effect of Low Dose Pancrelipase With an Oral Nutritional Supplement to Improve Nutrient Bioavailability in Patients at Increased Risk of Malnutrition
This will see if taking pancrelipase with oral nutritional supplements helps hospitalized adults aged 70 and older who are at risk of malnutrition absorb nutrients better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Kantonsspital Aarau Academic / other |
| Locations | 1 site (Aarau) |
| Trial ID | NCT06826105 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are hospitalized adults aged 70 or older at nutritional risk (NRS-2002 ≥3) who can eat orally and have eGFR ≥30 mL/min/1.73 m2, without a diagnosis of exocrine pancreatic insufficiency or recent major GI surgery.
Not a fit: Patients already diagnosed with exocrine pancreatic insufficiency and treated with pancreatic enzyme replacement, those with recent major GI resections or planned transplant/dialysis, terminally ill patients, or those with known hypersensitivity are unlikely to benefit from this intervention in the trial.
Why it matters
Potential benefit: If effective, adding pancrelipase to oral supplements could improve nutrient absorption and help reverse or limit malnutrition in older hospitalized patients, potentially improving recovery and quality of life.
How similar studies have performed: Pancrelipase is an established therapy for pancreatic exocrine insufficiency, but using it with oral nutritional supplements in older adults without EPI is a novel approach with limited prior clinical trial evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aarau
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.