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Can enzyme pills help after stomach surgery? new trial aims to find out

NCT ID NCT06058442

Symptom relief Sponsor: University of Leipzig Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether taking pancreatic enzyme capsules (NORTASE®) for six months can improve quality of life and prevent weight loss in people who have had most or all of their stomach removed. About 188 adults who had a gastrectomy will receive either the enzyme or a placebo. The main goal is to see if physical functioning improves.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NORTASE® (pancreatic enzymes)
What this could lead to
If it works, this could offer a way to improve quality of life and prevent weight loss after stomach removal surgery.
What could go wrong
This is a phase 3 trial, but it is still relatively small (188 people) and tests a specific supplement. The benefits may be modest and not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 188 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastrectomy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Carl-Thiem-Klinikum Cottbus gGmbH; 4. Medizinische Klinik

    RECRUITING

    Cottbus, 03048, Germany

  • Chirurgische Universitätsklinik, Universitätsklinikum Heidelberg

    RECRUITING

    Heidelberg, Germany

  • KEM | Evang. Kliniken Essen-Mitte gGmbH, Klinik für Internistische Onkologie

    RECRUITING

    Essen, Germany

  • Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Ulm

    RECRUITING

    Ulm, Germany

  • Klinik für Allgemein-, Viszeral- und Thoraxchirurgie; Klinikum Nürnberg

    RECRUITING

    Nuremberg, Germany

  • Klinik für Allgemein-, Viszeral- und Thoraxchirurgie; Universitätsklinikum Hamburg-Eppendorf

    RECRUITING

    Hamburg, Germany

  • Klinik für Allgemeine-, Viszerale-, und Transplantationschirurgie; Universitätsklinikum Tübingen

    RECRUITING

    Tübingen, Germany

  • Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie Universitätsklinikum Leipzig

    RECRUITING

    Leipzig, 04103, Germany

  • Klinikum St. Georg, Abteilung für Allgemein-, Viszeral- und Onkologische Chirurgie

    RECRUITING

    Leipzig, Germany

  • Sana Kliniken Leipziger Land GmbH, Klinik für Allgemein-, Viszeral-, MIC- und Gefäßchirurgie / Thoraxchirurgie

    RECRUITING

    Borna, Germany

  • UNIVERSITÄTSKLINIKUM FREIBURG Klinik für Allgemein- und Viszeralchirurgie Department Chirurgie

    RECRUITING

    Freiburg im Breisgau, 79106, Germany

  • Universitätsklinikum Jena, Allgemein-, Viszeral- und Gefäßchirurgie

    RECRUITING

    Jena, 07740, Germany

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