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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05070351
Other study ID # Pro00108517
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date January 3, 2022
Est. completion date October 2028

Study information

Verified date March 2024
Source Duke University
Contact James Ronald, MD PhD
Phone 919-684-7299
Email james.ronald@duke.edu
Is FDA regulated No
Health authority
Study type Interventional

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date October 2028
Est. primary completion date October 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Undergoing TIPS creation as part of routine clinical care - On PPIs therapy (at least 20 mg omeprazole equivalent daily) - Provision of signed and dated informed consent form by participant or legal representative - Stated willingness to comply with all study procedures and availability for the duration of the study - Male or female, age greater or equal to 18 Exclusion Criteria: - Grade IV esophagitis or gastric or duodenal ulcer - Recent endoscopic esophageal variceal band ligation necessitating PPI therapy for prevention of banding ulcer - Zollinger-Ellison syndrome - Active Helicobacter pylori infection - Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
PPI deprescribing
Patients currently on a proton pump inhibitor (PPI) undergoing transjugular intrahepatic portosystemic shunt (TIPS) creation as part of routine clinical care will be randomized to receive instructions to stop taking their PPI.

Locations

Country Name City State
United States Duke University Hospital Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in gastrointestinal tract microbiome Pre-TIPS to post-TIPS change in stool taxon abundances as measured by 16S rRNA sequencing Approximately 6-8 weeks
Primary Minimal hepatic encephalopathy Minimal hepatic encephalopathy, as assessed by psychometric hepatic encephalopathy score Approximately 6-8 weeks
Secondary Per-protocol evaluation of minimal hepatic encephalopathy Minimal hepatic encephalopathy, as assessed by psychometric hepatic encephalopathy score, based on actual reported PPI use Approximately 6-8 weeks
Secondary Chronic liver disease specific quality of life Chronic liver disease (CLDQ) specific QOL assessment Approximately 6-8 weeks
Secondary Gastroesophageal reflux specific quality of life Gastroesophageal reflux (QOLRAD) specific QOL assessment Approximately 6-8 weeks
Secondary Overt hepatic encephalopathy Episodes of overt hepatic encephalopathy (defined as West-Haven grade 2 or greater) Approximately 6-8 weeks
Secondary On-demand requirement for acid suppression therapy Proportion of patients in the PPI discontinuation arm needing on-demand H2 blockers or PPIs for gastroesophageal reflux symptoms Approximately 6-8 weeks
Secondary Adverse events Adverse events in the PPI continuation versus discontinuation arms Approximately 6-8 weeks
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