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Could common heartburn drugs raise brain risk after liver shunt?

NCT ID NCT05070351

Prevention Sponsor: Duke University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers are testing whether stopping proton pump inhibitors (PPIs) after a transjugular intrahepatic portosystemic shunt (TIPS) procedure can lower the risk of hepatic encephalopathy, a brain condition linked to liver disease. Adults already taking PPIs and scheduled for TIPS are randomly assigned to either continue or stop their PPI. The study measures changes in thinking tests and gut bacteria to see if PPI use affects hepatic encephalopathy risk.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
stopping proton pump inhibitors (PPI deprescribing)
What this could lead to
If stopping PPIs helps, doctors could change how they manage acid-suppressing drugs after TIPS, potentially lowering the chance of hepatic encephalopathy.
What could go wrong
This is a small early-phase trial with 33 patients, so results may not hold in larger groups. Stopping PPIs could also worsen acid-related conditions in some people.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

33 people

The number who actually took part.

Started

Jan 2022

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

hepatic encephalopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatic encephalopathy

Contacts and locations

Locations

  • Duke University Hospital

    Durham, North Carolina, 27710, United States

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