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Study on Stopping Esomeprazole in Patients with Liver Cirrhosis

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 studying the effects of stopping a type of medication called proton-pump inhibitors (PPIs) in patients with liver cirrhosis. Liver cirrhosis is a condition where the liver becomes severely scarred and is unable to function properly. The medication being studied is called Nexium, which contains the active ingredient esomeprazole magnesium trihydrate. This study will compare patients who stop taking Nexium with those who continue taking it, using a placebo for comparison.

The purpose of the study is to determine the time it takes for patients to experience their first unplanned re-hospitalization or death over a period of 12 months. Participants will be randomly assigned to either stop or continue their PPI treatment. The study will monitor various health outcomes, including any infections, liver-related complications, and changes in the gut bacteria over time.

Throughout the study, participants will be closely observed to gather information on their health status and any changes that occur. The trial aims to provide valuable insights into the effects of discontinuing long-term PPI therapy in individuals with liver cirrhosis, potentially guiding future treatment decisions for this condition.

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

    Joining the study

    Upon joining the study, the patient must have a confirmed diagnosis of liver cirrhosis. This can be determined through medical tests or a combination of clinical signs.

    The patient must have been treated with a proton-pump inhibitor (PPI) for at least 28 days before the study begins, with a standard dose taken daily for at least 7 days before the screening.

  2. Step 2

    Randomization

    The patient will be randomly assigned to one of two groups: the intervention group or the control group.

    The intervention group will stop taking the PPI, while the control group will continue the PPI treatment.

  3. Step 3

    Medication administration

    The medication used in the study includes esomeprazole magnesium trihydrate and a placebo. Both are administered orally in the form of gastro-resistant tablets.

    The dosage for the PPI, if continued, is 20 mg per day.

  4. Step 4

    Monitoring period

    The study will monitor the patient for a period of 12 months (360 days) to observe the time to first unplanned re-hospitalization or death.

    Regular assessments will be conducted to track any infections, liver-related complications, or gastrointestinal bleeding events.

  5. Step 5

    End of study

    At the end of the 12-month period, the study will conclude, and the patient's health outcomes will be evaluated.

    The primary focus will be on the time to first unplanned re-hospitalization or death, while secondary outcomes include any infections and changes in intestinal microbiota.

Who can join the trial?

10 criteria

  • Must be an adult, meaning 18 years or older.
  • Must have given written permission to participate, known as informed consent.
  • Must have liver cirrhosis, which is a condition diagnosed by tests or signs from the body.
  • Must have been in the hospital or recently hospitalized (within the last 42 days) due to complicated liver cirrhosis.
  • Must have been taking a type of medication called a proton-pump inhibitor (PPI) for at least 28 days before the study starts. PPIs are medicines that reduce stomach acid.
  • Must have been taking a single standard dose or less of PPI each day for at least 7 days before the study starts.
  • If female or male, must agree to follow the study's rules about preventing pregnancy.
  • If female, must not be pregnant or breastfeeding.
  • Must be able to understand the study information and personally sign and date the consent form before any study activities begin.
  • Must be willing to cooperate and be available for the entire duration of the study.

Who cannot join the trial?

4 criteria

  • Patients who do not have liver cirrhosis cannot participate. Liver cirrhosis is a condition where the liver is damaged and scarred.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are not willing to stop or continue their current proton-pump inhibitor (PPI) therapy as required by the study cannot participate. PPI therapy involves medications that reduce stomach acid.
  • Patients who are part of a vulnerable population, such as those with additional health conditions that make them more at risk, may not be eligible.
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Investigated drugs

Proton-Pump Inhibitors (PPIs) are medications that reduce the amount of acid produced in the stomach. They are commonly used to treat conditions like acid reflux, stomach ulcers, and other digestive issues. In this clinical trial, patients with liver cirrhosis are either continuing or discontinuing their long-term use of PPIs to see how it affects their health, specifically looking at the time to first unplanned re-hospitalization or death.

What is already known about the treatment

Proton-Pump Inhibitors (PPIs) – These medications are typically administered orally in the form of tablets or capsules. They are widely used in medicine to reduce stomach acid production and are well-documented in medical literature. The main therapeutic indications for PPIs include conditions like gastroesophageal reflux disease (GERD), stomach ulcers, and Zollinger-Ellison syndrome. At the molecular level, PPIs work by blocking the proton pump in the stomach lining, which is responsible for acid secretion. They belong to the pharmacological class of acid-suppressing agents.

Investigated diseases

Liver cirrhosis – Liver cirrhosis is a condition where the liver gradually becomes scarred and loses its ability to function properly. This scarring is often the result of long-term damage from factors like chronic alcohol use or viral hepatitis. As the disease progresses, the liver's ability to filter toxins, produce proteins, and store energy is impaired. Symptoms may include fatigue, jaundice, and swelling in the legs and abdomen. Over time, complications such as fluid buildup, infections, and bleeding can occur. The progression of cirrhosis can lead to liver failure if the underlying cause is not addressed.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-509863-26-00Protocol codeSTOPPITEstimated enrolment476 patientsSponsorUniversity Medical Center Hamburg-Eppendorf

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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