Actively Recruiting
The Pancreatic Enzymes After Gastrectomy Trial
Led by University of Leipzig · Updated on 2026-01-22
188
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of NORTASE4, a pancreatic enzyme treatment, compared to standard care in patients who have undergone gastrectomy, the surgical removal of part or all of the stomach. The trial aims to assess outcomes such as quality of life and weight changes in this patient group. This study is a Phase 3 randomized, double-blind trial sponsored by the University of Leipzig. Participants are randomly assigned to receive either 10 to 15 capsules of NORTASE4 or a placebo daily for a period of 6 months. The study compares these two groups to understand how NORTASE4 impacts patients after gastrectomy. Both treatments are given under double-blind conditions, meaning neither the participants nor the researchers know which treatment is being given during the study. During the 6-month study period, participants will be monitored with various assessments including disease-specific quality of life, weight, nutritional supplementation needs, and laboratory tests measuring serum hemoglobin, total protein, albumin, glucose, HbA1c, cholesterol, and vitamins A, B12, D, E, and K. Safety and adherence to treatment will be tracked throughout. The total duration of participation is about 6 months, after which data will be analyzed to determine the treatment effects.
CONDITIONS
Brief Title
The Pancreatic Enzymes After Gastrectomy Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gastrectomy (total or partial) with at least more than 50% of the stomach removed
- Age 18 years or older
- Written informed consent given
You will not qualify if you...
- Need for pancreatic enzyme therapy
- Gastrectomy done for palliative care
- UICC Stage IV gastric cancer
- Malnutrition from other causes
- Life expectancy under 12 months
- Known lactose intolerance
- Known hereditary galactose intolerance
- Use of alpha-glucosidase inhibitors (AGIs)
- Acute pancreatitis or acute episode of chronic pancreatitis
- Allergic to moulds or any ingredient of NORTASE4
- Participation in competing interventional trials allowed only under certain circumstances
- Under legal supervision or guardianship
- Dependent on the trial investigator or staff
- Fertile women within two years of last menstruation without proper contraception
- Pregnant or nursing women
- Suspected non-compliance
- Previous enrollment in this trial
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants take 10 to 15 capsules of either NORTASE® or placebo daily as part of the treatment.
Regular visits during the 6-month treatment period
Trial Site Locations
Total: 9 locations
1
Sana Kliniken Leipziger Land GmbH, Klinik für Allgemein-, Viszeral-, MIC- und Gefäßchirurgie / Thoraxchirurgie
Borna, Germany
Not Yet Recruiting
2
Carl-Thiem-Klinikum Cottbus gGmbH; 4. Medizinische Klinik
Cottbus, Germany, 03048
Actively Recruiting
3
KEM | Evang. Kliniken Essen-Mitte gGmbH, Klinik für Internistische Onkologie
Essen, Germany
Not Yet Recruiting
4
UNIVERSITÄTSKLINIKUM FREIBURG Klinik für Allgemein- und Viszeralchirurgie Department Chirurgie
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
5
Universitätsklinikum Jena, Allgemein-, Viszeral- und Gefäßchirurgie
Jena, Germany, 07740
Actively Recruiting
6
Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Actively Recruiting
7
Klinikum St. Georg, Abteilung für Allgemein-, Viszeral- und Onkologische Chirurgie
Leipzig, Germany
Actively Recruiting
8
Helios Kliniken Schwerin; Klinik für Allgemein- und Viszeralchirurgie
Schwerin, Germany, 19055
Actively Recruiting
9
Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Ulm
Ulm, Germany
Actively Recruiting
Research Team
A
Albrecht Hoffmeister, Prof. Dr.
A
Anett Schmiedeknecht, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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