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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
Male or female, age greater or equal to 18
Undergoing TIPS creation as part of routine clinical care
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 6-8 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 18 years old or older.
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I am scheduled for a TIPS procedure as part of my standard treatment.
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I am willing and able to follow all study rules and attend all appointments.
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I am taking daily acid reflux medication equivalent to 20 mg of omeprazole.

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

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

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
2,356 Previous Clinical Trials
3,419,085 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are receiving care through this clinical trial?

"That is correct. The information available on clinicaltrials.gov points to this study being actively recruiting patients as of now. 40 individuals are needed for the trial which is taking place at a single site."

Answered by AI

Are participants still being accepted for this research project?

"Yes, this information can be found on the website clinicaltrials.gov where it is stated that the trial is still recruiting patients."

Answered by AI
~27 spots leftby Oct 2028