Recruiting

Testing if stopping acid-reflux medicine is safe for people with liver disease

Plain-English translation of NCT04448028 on ClinicalTrials.gov ↗ · Source last updated April 2025 · Translation generated August 2026 · How we translate trials

Phase 4 — The treatment has already been approved. Researchers are tracking how it works in a large number of people over time.

What is this trial?

This trial is testing whether patients with advanced liver disease (cirrhosis) who are taking proton-pump inhibitors—a common acid-reflux medication—can safely stop the medication. Some research suggests that this medication might increase certain infection risks in people with liver cirrhosis, but other studies have not found this connection. This study will help doctors understand whether the risks of continuing the medication outweigh the benefits.

Doctors often prescribe this medication to people with liver cirrhosis to prevent stomach ulcers and bleeding, but recent evidence suggests it may increase the risk of serious infections and other complications. This trial will determine whether it's actually safe to stop taking this medication, or whether patients should continue using it.

Do you qualify?

You likely qualify if…

you have been diagnosed with liver cirrhosis (confirmed by biopsy or imaging)
you have been hospitalized recently (within the past 6 weeks) with complications from your liver disease
you have been taking acid-reflux medication daily for at least 28 days before joining the study
you are willing to take either the active medication or a placebo for one year
you are able to visit the hospital for study appointments and follow-up visits

You likely don't qualify if…

you have severe damage to your food pipe (esophagus) from acid reflux that has not been treated with the medication for at least 8 weeks
you have been diagnosed with a stomach ulcer within the past 4 weeks
you are taking blood-thinning or anti-inflammatory medications daily (except low-dose aspirin)
you are pregnant, breastfeeding, or unwilling to use contraception during the study
you have a life expectancy of less than one year due to cancer or other serious illnesses outside the liver

What participation looks like

You will be randomly assigned to either continue your regular acid-reflux medication or switch to a placebo (inactive pill). During the first two weeks, your dose will be gradually adjusted. Then you'll take either the active medication or placebo daily for one year. You'll need to attend regular visits to the hospital where doctors will check your health, perform blood tests, and monitor for any infections or other complications.

AI-generated summary from trial data · Aug 4, 2026 · Not medical advice

Trial locations(1 site)

Germany

University Medical Center Hamburg-Eppendorf, Hamburg, Free and Hanseatic City of Hamburg

Key details

Phase

Post-approval monitoring

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

German Federal Ministry of Education and Research, University Hospital Heidelberg

Enrollment target

~476 participants

Started

April 2021

Primary completion

February 2028

Age range

18 Years and older

Last updated on clinicaltrials.gov in April 2025.

Contact the research team directly

Reach out to the team running this trial. Response times vary — some teams are faster than others.

Central contact

STOPPIT Project Team

I. Department of Medicine, University Medical Center Hamburg-Eppendorf

Interested in joining?

Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.