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Study on the Effects of Amylase, Protease, and Rizolipase for Patients After Gastrectomy

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients who have undergone a gastrectomy, which is a surgical procedure to remove part or all of the stomach. The study is investigating whether taking a medication called Nortase® with every meal can improve the quality of life for these patients six months after their surgery. Nortase® is a medication that contains enzymes such as amylase, protease, and rizolipase, which help in digesting food.

The purpose of the study is to determine if enzyme supplementation can lead to better disease-specific quality of life for patients after a gastrectomy. Participants in the study will be randomly assigned to receive either Nortase® or a placebo, which is a substance with no active medication. The study will last for six months, during which participants will take the assigned capsules with their meals.

Throughout the study, participants will be monitored to assess their quality of life, focusing on physical well-being. The goal is to see if those taking Nortase® experience improvements compared to those taking the placebo. This research aims to provide valuable insights into the potential benefits of enzyme supplementation for individuals recovering from gastrectomy.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    Upon joining the study, you will be officially enrolled as a participant. This involves confirming that you meet the criteria for the trial, such as having undergone a gastrectomy and being 18 years or older.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate your current health status. This may include physical examinations and questionnaires to understand your quality of life after gastrectomy.

  3. Step 3

    Medication administration

    You will be provided with either the study medication, Nortase®, or a placebo. Nortase® contains enzymes such as amylase, protease, and rizolipase. The medication is in the form of a hard capsule and is taken orally.

    The dosage involves taking the capsule with every meal. This will continue for the duration of the study, which is up to 6 months.

  4. Step 4

    Regular follow-ups

    Throughout the study, regular follow-up appointments will be scheduled. These appointments are designed to monitor your health and any changes in your quality of life. You may be asked to complete additional questionnaires and undergo further assessments.

  5. Step 5

    Final assessment

    At the end of the 6-month period, a final assessment will be conducted. This will involve a comprehensive evaluation of your quality of life and physical health, using tools such as the EORTC-QLQ-C30 questionnaire.

Who can join the trial?

3 criteria

  • Must have had a gastrectomy (surgery to remove part or all of the stomach).
  • Must be 18 years of age or older.
  • Both men and women can participate.

Who cannot join the trial?

1 criterion

  • Patients who have had a **gastrectomy** (surgery to remove part or all of the stomach).
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Investigated drugs

Pancreatic Enzymes are supplements that help your body digest food. After a gastrectomy, which is a surgery to remove part or all of the stomach, your body might not produce enough enzymes to break down food properly. Taking pancreatic enzyme supplements with every meal can help improve digestion and make it easier for your body to absorb nutrients. This can lead to a better quality of life by reducing symptoms like bloating, gas, and diarrhea, which are common after this type of surgery.

What is already known about the treatment

Pancreatic Enzyme Supplementation – This medication is administered orally in the form of capsules or tablets, taken with meals. It is currently being studied in clinical trials to assess its effectiveness in improving the quality of life for patients who have undergone gastrectomy, which is the surgical removal of part or all of the stomach. The main therapeutic indication is to aid digestion by supplementing the body's natural enzymes, which may be reduced after such surgery. At the molecular level, these enzymes help break down food into nutrients that the body can absorb. This medication is classified as a digestive enzyme supplement.

Investigated diseases

Post-gastrectomy syndrome – This condition occurs after the surgical removal of all or part of the stomach, known as gastrectomy. It involves a range of symptoms that arise due to changes in digestion and nutrient absorption. Common symptoms include early satiety, abdominal pain, nausea, and diarrhea. The progression of the syndrome can lead to nutritional deficiencies and weight loss due to the altered digestive process. Over time, patients may experience changes in their metabolism and energy levels. The severity and specific symptoms can vary depending on the extent of the stomach removal and individual patient factors.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501944-14-00Protocol codePANEMEstimated enrolment188 patientsSponsorUniversitaet Leipzig

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