Hepatic EncephalopathyPhase 1/2NCT05070351
Deprescribing Proton Pump Inhibitors to Reduce Post-TIPS Hepatic Encephalopathy
A Phase 1/2 study testing PPI deprescribing in people with Hepatic Encephalopathy, run by Duke University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Encephalopathy
- What is being tested?
- PPI deprescribing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2022to 2 Jun 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27710
About this study
Official title: A Randomized Open-label Trial of Deprescribing Proton Pump Inhibitors to Reduce the Risk of Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt Creation
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.
- Conditions
- Hepatic Encephalopathy
- Being tested
- PPI deprescribing
- Medical subject headings
- Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPI deprescribingDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| PPI deprescribing arm | Experimental | Patients taking a PPI (at least 20 mg omeprazole equivalent daily) will be instructed to stop taking their PPI. Receives: Drug: PPI deprescribing |
| PPI continuation arm | No intervention | Patients will be instructed to continue taking their PPI (at least 20 mg omeprazole equivalent daily) as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Minimal Hepatic Encephalopathy
Minimal hepatic encephalopathy, as assessed by psychometric hepatic encephalopathy score (PHES). Reported as the number of mistakes on line tracing test after TIPS compared to baseline (possible values range from - infinity to + infinity). Higher numbers indicate more errors.
Measured: Baseline (before transjugular intrahepatic portosystemic shunt - TIPS), after TIPS (approximately 6-8 weeks)
Secondary outcomes (5)
Change in Per-protocol Evaluation of Minimal Hepatic Encephalopathy
Minimal hepatic encephalopathy, as assessed by psychometric hepatic encephalopathy score, based on actual reported PPI (Proton Pump Inhibitors) use. Reported as the number of mistakes on line tracing test after TIPS compared to baseline (possible values range from - infinity to + infinity). Higher numbers indicate more errors.
Measured: Baseline (before TIPS), after TIPS (approximately 6-8 weeks)
Change in Chronic Liver Disease Specific Quality of Life (CLDQ)
Chronic liver disease (CLDQ) specific QOL assessment. Reported as the score difference after TIPS compared to baseline (possible range -174 to +174). Higher numbers indicate worse quality of life.
Measured: Baseline (TIPS), after TIPS (approximately 6-8 weeks)
Change in Gastroesophageal Reflux Specific Quality of Life
Gastroesophageal reflux (QOLRAD) specific QOL assessment. Reported as the score difference after TIPS compared to baseline (possible range -150 to +150). Higher numbers indicate worse quality of life.
Measured: Baseline (TIPS), after TIPS (approximately 6-8 weeks)
Number of Participants Diagnosed With Overt Hepatic Encephalopathy
Number of participants with episodes of overt hepatic encephalopathy (defined as West-Haven grade 2 or greater)
Measured: Approximately 6-8 weeks
Number of Participants With Adverse Events
Adverse events in the PPI continuation versus discontinuation arms
Measured: Approximately 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start3 Jan 2022
- Primary completion2 Jun 2025
- Study completion2 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Ronald, MD PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070351
- Sponsor's protocol ID
- Pro00108517
- Status last verified
- Aug 2026
- First submitted
- 27 Sep 2021
- Last updated
- 10 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open-label Trial of Deprescribing Proton Pump Inhibitors to Reduce the Risk of Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt Creation
- ClinicalTrials.gov ID
- NCT05070351
- Acronym / sponsor ID
- Pro00108517
- Conditions
- Hepatic Encephalopathy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 2 Jun 2025 (actual)
- Study completion
- 2 Jun 2025 (actual)
- First posted
- 7 Oct 2021 (actual)
- Results
- Posted 10 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPI deprescribing arm | Experimental | Drug: PPI deprescribingPatients taking a PPI (at least 20 mg omeprazole equivalent daily) will be instructed to stop taking their PPI. |
| PPI continuation arm | No intervention | –Patients will be instructed to continue taking their PPI (at least 20 mg omeprazole equivalent daily) as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPI deprescribingPatients 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. | Drug | PPI deprescribing arm |
Primary outcome
Change in Minimal Hepatic Encephalopathy
Time frame: Baseline (before transjugular intrahepatic portosystemic shunt - TIPS), after TIPS (approximately 6-8 weeks)
Minimal hepatic encephalopathy, as assessed by psychometric hepatic encephalopathy score (PHES). Reported as the number of mistakes on line tracing test after TIPS compared to baseline (possible values range from - infinity to + infinity). Higher numbers indicate more errors.
5 secondary outcomes
Change in Per-protocol Evaluation of Minimal Hepatic Encephalopathy
Time frame: Baseline (before TIPS), after TIPS (approximately 6-8 weeks)
Change in Chronic Liver Disease Specific Quality of Life (CLDQ)
Time frame: Baseline (TIPS), after TIPS (approximately 6-8 weeks)
Change in Gastroesophageal Reflux Specific Quality of Life
Time frame: Baseline (TIPS), after TIPS (approximately 6-8 weeks)
Number of Participants Diagnosed With Overt Hepatic Encephalopathy
Time frame: Approximately 6-8 weeks
Number of Participants With Adverse Events
Time frame: Approximately 6-8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Ronald, MD PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PPI deprescribing in people with Hepatic Encephalopathy, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Minimal Hepatic Encephalopathy (time frame: Baseline (before transjugular intrahepatic portosystemic shunt - TIPS), after TIPS (approximately 6-8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.