Proton Pump Inhibitor Deprescribing for Hepatic Encephalopathy
Trial Summary
What is the purpose of this trial?
A total of 40 patients taking proton pump inhibitors (PPIs) who undergo transjugular intrahepatic portosystemic shunt (TIPS) creation as part of routine clinical care will be randomized in 1:1 fashion to either continue or discontinue their PPIs to determine whether these commonly used gastric acid suppressing agents increase risk of post-TIPS hepatic encephalopathy (HE). Patients will be assessed for symptoms of minimal HE (MHE), using the established psychometric hepatic encephalopathy score (PHES) battery of tests. MHE assessment will be conducted at two timepoints: at baseline prior to randomization and TIPS creation and approximately 4 weeks after randomization and TIPS creation. Stool samples will also be collected at both timepoints to allow characterization of the gastrointestinal (GI) tract microbiome using 16S rRNA sequencing. The pre to post-TIPS change in PHES scores will be compared between patients randomized to continue versus discontinue their PPIs. Quality of life (QOL) will also be assessed. Changes in the GI tract microbiome will be analyzed to determine whether this represents a potential biological mechanism linking PPI use with post-TIPS HE.
Will I have to stop taking my current medications?
The trial involves patients who are currently taking proton pump inhibitors (PPIs). Participants will be randomly assigned to either continue or stop their PPIs, so you may or may not have to stop taking them depending on your group.
How does the drug for hepatic encephalopathy differ from other treatments?
The treatment involves deprescribing proton pump inhibitors (PPIs), which are typically used to reduce stomach acid, rather than directly targeting hepatic encephalopathy. This approach is unique because it focuses on reducing potential side effects or complications from PPIs that may worsen liver conditions, rather than adding new medications.12345
Research Team
James Ronald, MD PhD
Principal Investigator
Duke University
Eligibility Criteria
This trial is for adults 18 or older who are already taking proton pump inhibitors (PPIs) and will undergo a TIPS procedure as part of their usual care. They must be willing to follow the study rules and be available for its duration. People can't join if they're pregnant, have severe esophagitis or ulcers, need PPIs after certain esophageal procedures, have Zollinger-Ellison syndrome, or an active Helicobacter pylori infection.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline assessment of minimal hepatic encephalopathy (MHE) and stool sample collection prior to randomization and TIPS creation
Treatment
Randomization to either continue or discontinue PPIs, with follow-up assessment of MHE and stool sample collection approximately 4 weeks after TIPS creation
Follow-up
Participants are monitored for safety, quality of life, and changes in gastrointestinal tract microbiome
Treatment Details
Interventions
- PPI
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Who Is Running the Clinical Trial?
Duke University
Lead Sponsor