Evaluating NORTASE® for patients after stomach surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial assesses the impact of NORTASE®, an enzyme supplement, on the quality of life and weight of patients who have undergone gastrectomy, compared to standard care. It aims to determine whether enzyme supplementation can improve post-operative outcomes in this patient population. Participants will be randomly assigned to receive either NORTASE® or a placebo, and their progress will be monitored throughout the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Gastrectomy (total and partial distal); at least \> 50 % of the stomach must be resected
2. Age 18 or older
3. Written informed consent

Exclusion Criteria:

1. Indication for pancreas enzyme therapy
2. Gastrectomy with palliative intention
3. UICC (Union for International Cancer Control) Stage IV gastric malignancy
4. Malnutrition of other aetiology
5. Life expectancy \< 12 months
6. Known lactose intolerance
7. Known hereditary galactose intolerance
8. Patients on alpha-glucosidase inhibitors (AGIs)
9. Acute pancreatitis
10. Acute episode of chronic pancreatitis
11. Known hypersensitivity to moulds (mould allergy) or any other ingredient of NORTASE®
12. Participation in competing interventional trials may be allowed under circumstances
13. Patients under legal supervision or guardianship
14. Patients who are dependent on the investigator or the medical staff of the trial team or the coordinating investigator or the sponsor
15. Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) while participating in the trial
16. Pregnant or nursing women
17. Suspected lack of compliance
18. Patients who were already enrolled in the trial

Where it's running

• Sana Kliniken Leipziger Land GmbH, Klinik für Allgemein-, Viszeral-, MIC- und Gefäßchirurgie / Thoraxchirurgie
  Borna, Germany Recruiting
• Carl-Thiem-Klinikum Cottbus gGmbH; 4. Medizinische Klinik
  Cottbus, Germany Recruiting
• KEM | Evang. Kliniken Essen-Mitte gGmbH, Klinik für Internistische Onkologie
  Essen, Germany Recruiting
• UNIVERSITÄTSKLINIKUM FREIBURG Klinik für Allgemein- und Viszeralchirurgie Department Chirurgie
  Freiburg im Breisgau, Germany Recruiting
• Klinik für Allgemein-, Viszeral- und Thoraxchirurgie; Universitätsklinikum Hamburg-Eppendorf
  Hamburg, Germany Recruiting
• Chirurgische Universitätsklinik, Universitätsklinikum Heidelberg
  Heidelberg, Germany Recruiting

Study contacts

• Principal investigator: Albrecht Hoffmeister, Prof. Dr. — Universität Leipzig
• Study coordinator: Albrecht Hoffmeister, Prof. Dr.
• Email: Albrecht.Hoffmeister@medizin.uni-leipzig.de
• Phone: +4934197

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.