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Proton Pump Inhibitor Deprescribing for Hepatic Encephalopathy

Phase 1 & 2
Recruiting
Led By James Ronald, MD PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing TIPS creation as part of routine clinical care
On PPIs therapy (at least 20 mg omeprazole equivalent daily)
Must not have
Grade IV esophagitis or gastric or duodenal ulcer
Zollinger-Ellison syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 6-8 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether proton pump inhibitors increase the risk of hepatic encephalopathy after transjugular intrahepatic portosystemic shunt creation. Patients will be assessed for symptoms and given tests at two time points. Stool samples will also be collected to allow characterization of the gastrointestinal tract microbiome.

Who is the study for?
This trial is for adults 18 or older who are already taking proton pump inhibitors (PPIs) and will undergo a TIPS procedure as part of their usual care. They must be willing to follow the study rules and be available for its duration. People can't join if they're pregnant, have severe esophagitis or ulcers, need PPIs after certain esophageal procedures, have Zollinger-Ellison syndrome, or an active Helicobacter pylori infection.
What is being tested?
The trial aims to see if stopping PPIs reduces brain dysfunction (hepatic encephalopathy) after a TIPS procedure. Participants are randomly chosen to either stop or continue their PPI medication. Their brain function and quality of life are measured before and about four weeks after the TIPS procedure.
What are the potential side effects?
While not directly related to side effects from medications, participants may experience changes in digestive symptoms due to altering their PPI therapy. Additionally, there might be variations in gut bacteria which could potentially affect overall health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a TIPS procedure as part of my standard treatment.
Select...
I am taking daily acid reflux medication equivalent to 20 mg of omeprazole.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have severe esophagitis or a serious stomach or duodenal ulcer.
Select...
I have Zollinger-Ellison syndrome.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 6-8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 6-8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Minimal hepatic encephalopathy
Secondary study objectives
Adverse events
Chronic liver disease specific quality of life
Gastroesophageal reflux specific quality of life
+3 more
Other study objectives
Change in gastrointestinal tract microbiome

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PPI deprescribing armExperimental Treatment1 Intervention
Patients taking a PPI (at least 20 mg omeprazole equivalent daily) will be instructed to stop taking their PPI.
Group II: PPI continuation armActive Control1 Intervention
Patients will be instructed to continue taking their PPI (at least 20 mg omeprazole equivalent daily) as usual.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,455 Previous Clinical Trials
2,971,512 Total Patients Enrolled
James Ronald, MD PhDPrincipal InvestigatorDuke University

Media Library

PPI deprescribing Clinical Trial Eligibility Overview. Trial Name: NCT05070351 — Phase 1 & 2
Encephalopathy Research Study Groups: PPI deprescribing arm, PPI continuation arm
Encephalopathy Clinical Trial 2023: PPI deprescribing Highlights & Side Effects. Trial Name: NCT05070351 — Phase 1 & 2
PPI deprescribing 2023 Treatment Timeline for Medical Study. Trial Name: NCT05070351 — Phase 1 & 2
~23 spots leftby Oct 2028
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