💬In plain words
What the trial is, and whether it could suit you
Proton-pump inhibitors (PPI) are commonly prescribed in an uncritical manner to patients with liver cirrhosis without a clear evidence-based indication. Observational studies suggests that PPI use in cirrhotic patients may be a risk factor for the development of infections, especially spontaneous bacterial peritonitis (SBP). A possible explanation are PPI-associated microbiotic shifts leading to small intestinal bacterial overgrowth with subsequently increased bacterial translocation. Furthermore, PPI therapy in cirrhotic patients may lead to an increased risk for pneumonia and Clostridium difficile-infections.
However, the evidence is ambiguous, as other published studies found no evidence for an association of PPI use with an increased risk for SBP or pneumonia.
Moreover, an association between episodes of hepatic encephalopathy and PPI use has been reported.
Infections and hepatic
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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