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NCT05070351 · ClinicalTrials.gov registry record · Phase 1
Deprescribing Proton Pump Inhibitors to Reduce Post-TIPS Hepatic Encephalopathy
A Phase 1 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT05070351 is a Phase 1 study that has completed, run by Duke University. The registered enrollment target is 33 participants.
The verdict
NCT05070351, a Phase 1 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study 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.
Interventions
- DRUG PPI deprescribing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2022-01-03 |
| Est. Completion | 2025-06-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05070351
The ClinicalTrials.gov registry entry for NCT05070351 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PPI deprescribing is the first listed.
NCT05070351 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05070351 about?
NCT05070351 is a clinical study titled "Deprescribing Proton Pump Inhibitors to Reduce Post-TIPS Hepatic Encephalopathy". 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 ...
What is the current status of trial NCT05070351?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2022-01-03. Estimated completion is 2025-06-02.
What interventions are being tested in trial NCT05070351?
The interventions under investigation include: PPI deprescribing (DRUG).
Who is sponsoring clinical trial NCT05070351?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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