Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05070351
Study type Interventional
Source Duke University
Contact James Ronald, MD PhD
Phone 919-684-7299
Email [email protected]
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date October 2021
Completion date October 2023

See also
  Status Clinical Trial Phase
Completed NCT01559519 - Post Transjugular Intrahepatic Portosystemic Shunt (Tips) Albumine Infusion to Prevent Hepatic Encephalopathy Phase 4
Terminated NCT01846806 - The Role of Bacterial Overgrowth and Delayed Intestinal Transit in Hepatic Encephalopathy. N/A
Recruiting NCT01178372 - Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis Phase 4
Completed NCT00914056 - A Study of Controlled Lactulose Withdrawal N/A
Completed NCT00740142 - Efficacy of Combined Oral L-ornithine-L-aspartate and Lactulose in Patients With Hepatic Encephalopathy Phase 4
Completed NCT00558038 - Safety and Efficacy of AST-120 Compared to Lactulose in Patients With Hepatic Encephalopathy Phase 2
Completed NCT00986895 - A Study of Glyceryl Tri-(4-phenylbutyrate) Administered Orally as a Single Dose, and Twice Daily for Seven Consecutive Days to Subjects With Hepatic Impairment With Cirrhosis and to a Control Group Phase 1
Completed NCT00287235 - Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS) N/A
Recruiting NCT04096014 - Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy N/A
Recruiting NCT04082780 - Rifamycin in Minimal Hepatic Encephalopathy Phase 2
Recruiting NCT04415294 - Flicker App for Minimal Hepatic Encephalopathy
Not yet recruiting NCT05071716 - Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis Phase 3
Withdrawn NCT02086825 - A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Renal Failure Phase 3
Completed NCT02636647 - Fecal Transplant in Recurrent Hepatic Encephalopathy Phase 1
Completed NCT01446523 - S. Endotoxin, Inflammatory Mediators and MRS Before and After Treatment in MHE N/A
Completed NCT01218568 - Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial N/A
Completed NCT01008293 - Effect of Probiotics in Treatment of Minimal Hepatic Encephalopathy (MHE) and Health Related Quality of Life Phase 2/Phase 3
Completed NCT00533910 - Rifaximin in Minimal Hepatic Encephalopathy N/A
Completed NCT00433368 - Efficacy of L-Ornithine-L-Aspartate in Cirrhotics With Hepatic Encephalopathy Phase 3
Recruiting NCT03372499 - Diet Management on Hepatic Encephalopathy of Patients With Variceal Bleeding After Intrahepatic Portosystemic Shunt Creation N/A