Stopping proton-pump inhibitors in patients with liver cirrhosis

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 clinical trial investigates the effects of discontinuing proton-pump inhibitors (PPIs) in patients with liver cirrhosis who have been hospitalized for related complications. It is a double-blind, placebo-controlled trial where participants will receive either a placebo or Esomeprazole, a common PPI, to assess the impact on infection rates and hepatic encephalopathy. The study aims to clarify the ambiguous evidence surrounding PPI use in cirrhotic patients and its potential risks. By evaluating these outcomes, the trial seeks to provide clearer guidelines for PPI use in this vulnerable population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with liver cirrhosis. The diagnosis of liver cirrhosis may be based on histology or a combination of clinical, laboratory and radiological criteria.
* Hospitalization or recent hospitalization (0 to 42 days prior to the baseline visit) with complications of liver cirrhosis.
* Treatment with proton pump inhibitors (PPI) for at least 28 days prior to the screening visit.
* PPI treatment with a single standard dose/day or less for at least 7 days prior to the screening visit.
* Females/males who agree to comply with the applicable contraceptive requirements of the protocol.
* Non-pregnant, non-lactating females.
* Ability to understand the patient information and to personally sign and date the informed consent to participate in the study, before completing any study related procedures.
* The patient is co-operative and available for the entire study.
* Provided written informed consent.

Exclusion Criteria:

* Diagnosis of severe reflux esophagitis (LA grade C or D) by EGD \< 2 months prior to the screening visit without PPI-therapy for at least 8 weeks prior to the screening visit.
* Peptic ulcers diagnosed by EGD \< 28 days prior to the screening visit.
* History of endoscopic therapy for esophageal varices \< 14 days prior to the screening visit.
* Life-expectancy \< 1 year (at the discretion of the investigator) due to extrahepatic malignancies, metastasized hepatocellular carcinoma (HCC) or other severe extrahepatic diseases. Importantly, HCC without extrahepatic metastases or a reduced life-expectancy of \< 1 year due to liver cirrhosis are not regarded as exclusion criteria.
* Regular intake of non-steroidal anti-inflammatory drugs (NSAID) on a daily basis with the exemption of acetylsalicylic acid (ASS) 100mg/day orally.
* Hypersensitivity or intolerance to esomeprazole, substituted benzimidazoles or other excipients of the IMP.
* Ongoing therapy with nelfinavir.
* Participation in a clinical trial or use of an IMP within 30 days or five times the half-life of the IMP - whichever is longer - prior to receiving the first dose within this study.
* Positive urine pregnancy test at screening or positive serum pregnancy test before the first treatment or is breast feeding.
* Patient is not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of IMP.

Where it's running

• University Medical Center Hamburg-Eppendorf
  Hamburg, Free and Hanseatic City of Hamburg, Germany Recruiting

Study contacts

• Principal investigator: Johannes Kluwe, MD — I. Department of Medicine, University Medical Center Hamburg-Eppendorf
• Study coordinator: STOPPIT Project Team
• Email: STOPPIT@uke.de
• Phone: +494074100

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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.