Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT06826105
Status:
RECRUITING
Last Update Posted:
2025-09-30
First Post:
2025-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pancrelipase With Nutritional Supplement in Patients at Risk of Malnutrition (EFFORT-ENZO)
Sponsor:
Philipp Schuetz
Organization:
Study Overview
Official Title:
Effect of Low Dose Pancrelipase With an Oral Nutritional Supplement to Improve Nutrient Bioavailability in Patients at Increased Risk of Malnutrition
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: