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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-22

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pancrelipase

two capsules each containing 15000 USP units of lipase

Group Type EXPERIMENTAL

Zenpep

Intervention Type DRUG

two capsules (each containing 15000 USP units of lipase) together with nutritional supplements

Placebo

two capsules each containing placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

two capsules (containing placebo) together with nutritional supplements

Interventions

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Zenpep

two capsules (each containing 15000 USP units of lipase) together with nutritional supplements

Intervention Type DRUG

Placebo

two capsules (containing placebo) together with nutritional supplements

Intervention Type DRUG

Other Intervention Names

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Pancrelipase lactose monohydrate

Eligibility Criteria

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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

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No