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Study identifier: NCT04448028 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Stop of Proton-pump Inhibitor Treatment in Patients With Liver Cirrhosis - a Double-blind, Placebo-controlled Trial

Condition: Liver Cirrhosis  ·  Sponsor: Universitätsklinikum Hamburg-Eppendorf

PhasePhase 4
Planned participants476
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 encephalopathy may often lead to a hospitalization of cirrhotic patients and PPI use at discharge has also been associated to early re-hospitalization. While some studies found an association of PPI and increased mortality in cirrhotic patients, other studies could not observe this association. Thus, some of the current evidence suggests an unfavourable risk profile of PPIs in patients with liver cirrhosis. However, this patient population is considered to be at a high risk of gastrointestinal haemorrhage from peptic ulcers. Importantly, patients with liver cirrhosis have an increased mortal…

This description comes directly from the study's public registry record.

Talk to the study team

STOPPIT Project Team  ·  +494074100  ·  STOPPIT@uke.de

Malte H Wehmeyer, MD  ·  +494074100  ·  m.wehmeyer@uke.de

Always discuss trial participation with your own doctor first.

Locations (1)

University Medical Center Hamburg-EppendorfHamburg, Free and Hanseatic City of Hamburg, GermanyRecruiting

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Source record: clinicaltrials.gov/study/NCT04448028