Pancrelipase With Nutritional Supplement in Patients at Risk of Malnutrition (EFFORT-ENZO)

Philipp Schuetz

Status: Enrolling

Conditions: Malnutrition

Treatments: Drug: Placebo; Drug: Zenpep

Study type: Interventional

Funder types: Other

Identifiers

NCT06826105

2024-02519 ka24Schuetz;

Details and patient eligibility

About

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.

Full description

This study investigates whether adding digestive pancreatic enzymes to oral nutritional supplements (ONS) can improve nutrient absorption in older adults at risk of malnutrition. While ONS are commonly recommended, their effectiveness is often limited due to age-related declines in exocrine pancreatic function, leading to reduced enzyme secretion. Studies indicate that pancreatic lipase levels decline with age, potentially impairing nutrient digestion and absorption.

The study proposes using pancrelipase (Zenpep®), an FDA-approved pancreatic enzyme replacement therapy, to enhance nutrient bioavailability. The randomized, placebo-controlled trial will assess whether pancrelipase improves postprandial levels of amino acids, fatty acids, and glucose in hospitalized patients at nutritional risk.

The study aims to determine if pancreatic enzyme supplementation can enhance nutrient absorption and provide a novel strategy for managing malnutrition in older adults without diagnosed exocrine pancreatic insufficiency (EPI). If successful, this approach could improve clinical outcomes, reduce healthcare costs, and enhance quality of life.

Enrollment: 20 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Pancrelipase

Experimental group

Description:

two capsules each containing 15000 USP units of lipase

Treatment:

Drug: Zenpep

Placebo

Placebo Comparator group

Description:

two capsules each containing placebo

Treatment:

Drug: Placebo