PPI deprescribing for Encephalopathy

Phase 1 & 2
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
Be older than 18 years old
Must not have
Be younger than 18 years old
Screening 3 weeks
Treatment Varies
Follow Upapproximately 6-8 weeks
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Liver Encephalopathy


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

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 site

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,290 Previous Clinical Trials
3,100,777 Total Patients Enrolled
James Ronald, MD PhDPrincipal Investigator
Duke 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
~15 spots leftby Oct 2024