Proton Pump Inhibitor Adverse ReactionNCT06384443
Proton Pump Inhibitors in Cirrhotic Patients
An observational study of Proton Pump Inhibitor Adverse Reaction and Liver Cirrhosis, run by National Liver Institute, Egypt at 1 site in Egypt.
Trial summary
Proton pump inhibitors (PPIs) inappropriate use, in patients with cirrhosis, presents a significant clinical challenge. This study evaluates overprescription and misuse of PPIs in cirrhotic patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Proton Pump Inhibitor Adverse Reaction, Liver Cirrhosis
- How many people
- 1,000 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: Patients with a histological, biochemical, imaging and/or clinical data of cirrhosis
Who may be able to join
- Patients receiving proton pump inhibitors at the time of enrollment.
Who cannot join
- Refusal to sign the informed consent form or failure to provide the required information
Trial locations and contacts
1 site in 1 country.
Egypt1 site
National Liver institute - Menoufia University
Shibīn al Kawm, Menoufia, 32511
About this study
Official title: Inappropriate Use of Proton Pump Inhibitors in Patients With Liver Cirrhosis
Proton pump inhibitors (PPIs) inappropriate use, in patients with cirrhosis, presents a significant clinical challenge. This study evaluates overprescription and misuse of PPIs in cirrhotic patients. The patterns of use of PPIs will be classified into two groups based on adherence to the proven indications: Group A: Inappropriate use of PPI, Group B: Appropriate use of PPI. We will estimate the prevalence of PPI misuse in cirrhotics and correlate it with different factors.
Read the detailed description
The inappropriate use of PPIs in cirrhosis patients is a growing concern. Evidence supporting the use of PPIs in cirrhosis-related conditions is limited. Several adverse outcomes have been linked to PPI use in cirrhosis, including an increased risk of spontaneous bacterial peritonitis and hepatic encephalopathy.
The study aimed to assess the appropriateness of prescribing PPIs to patients with cirrhosis, examining its impact on prescribing practices and identifying associated factors.
in this observational, descriptive, cross-sectional study, cirrhotic patients receiving proton pump inhibitors will be included in the study. Enrolled patients will classified according to the indication for PPI administration: Group A: Inappropriate use of PPI, Group B: Appropriate use of PPI. Use of PPI will be considered inappropriate when prescribed without approved indication or used for a prolonged period beyond the recommended duration. The prevalence of PPI misuse in cirrhotics will be estimated and multivariate analyses will be conducted in order to identify independent predictors of inappropriate use of PPI.
- Keywords
- Proton pump inhibitors, liver cirrhosis, spontaneous bacterial peritonitis, hepatic encephalopathy, portal hypertension
- Medical subject headings
- Liver Cirrhosis, Hepatic Encephalopathy, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Inappropriate use of PPI | PPI is prescribed without approved indication or used for a prolonged period beyond the recommended duration. | |
| Appropriate use of PPI | PPI is prescribed for the approved indication and used within the recommended duration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inappropriate use of PPIs
Explore the prevalence of using PPIs without approved indication or for a prolonged period beyond the recommended duration in patients with liver cirrhosis
Measured: Six weeks after study completion
Predictors for inappropriate use of PPIs
Determine independent predictors of inappropriate use of PPIs in patients with liver cirrhosis using multivariate analyses.
Measured: Eight weeks after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 Oct 2020
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Proton Pump Inhibitor Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Liver Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gasser I El-Azab, M.D., Principal investigator, National Liver Institute, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384443
- Sponsor's protocol ID
- 01001099646
- Status last verified
- Apr 2024
- First submitted
- 22 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El-Azab G, Zakareya T, Abdel Aleem M, Edrees A. Inappropriate use of proton pump inhibitors in patients with liver cirrhosis: a cross-sectional study. Eur J Gastroenterol Hepatol. 2025 Oct 1;37(10):1141-1146. doi: 10.1097/MEG.0000000000002985. Epub 2025 Apr 29.
PubMed 40359285
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inappropriate Use of Proton Pump Inhibitors in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT06384443
- Acronym / sponsor ID
- 01001099646
- Keywords
- Proton pump inhibitors, liver cirrhosis, spontaneous bacterial peritonitis, hepatic encephalopathy, portal hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- National Liver Institute, EgyptUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Proton pump inhibitors (PPIs) inappropriate use, in patients with cirrhosis, presents a significant clinical challenge. This study evaluates overprescription and misuse of PPIs in cirrhotic patients. The patterns of use of PPIs will be classified into two groups based on adherence to the proven indications: Group A: Inappropriate use of PPI, Group B: Appropriate use of PPI. We will estimate the prevalence of PPI misuse in cirrhotics and correlate it with different factors.
Detailed description
The inappropriate use of PPIs in cirrhosis patients is a growing concern. Evidence supporting the use of PPIs in cirrhosis-related conditions is limited. Several adverse outcomes have been linked to PPI use in cirrhosis, including an increased risk of spontaneous bacterial peritonitis and hepatic encephalopathy.
The study aimed to assess the appropriateness of prescribing PPIs to patients with cirrhosis, examining its impact on prescribing practices and identifying associated factors.
in this observational, descriptive, cross-sectional study, cirrhotic patients receiving proton pump inhibitors will be included in the study. Enrolled patients will classified according to the indication for PPI administration: Group A: Inappropriate use of PPI, Group B: Appropriate use of PPI. Use of PPI will be considered inappropriate when prescribed without approved indication or used for a prolonged period beyond the recommended duration. The prevalence of PPI misuse in cirrhotics will be estimated and multivariate analyses will be conducted in order to identify independent predictors of inappropriate use of PPI.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inappropriate use of PPI | – | –PPI is prescribed without approved indication or used for a prolonged period beyond the recommended duration. |
| Appropriate use of PPI | – | –PPI is prescribed for the approved indication and used within the recommended duration. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with a histological, biochemical, imaging and/or clinical data of cirrhosis
Key inclusion criteria (1 listed)
- Patients receiving proton pump inhibitors at the time of enrollment.
Key exclusion criteria (1 listed)
- Refusal to sign the informed consent form or failure to provide the required information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inappropriate use of PPIs
Time frame: Six weeks after study completion
Explore the prevalence of using PPIs without approved indication or for a prolonged period beyond the recommended duration in patients with liver cirrhosis
Predictors for inappropriate use of PPIs
Time frame: Eight weeks after study completion
Determine independent predictors of inappropriate use of PPIs in patients with liver cirrhosis using multivariate analyses.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Derived from this study: PubMed 40359285El-Azab G, Zakareya T, Abdel Aleem M, Edrees A. Inappropriate use of proton pump inhibitors in patients with liver cirrhosis: a cross-sectional study. Eur J Gastroenterol Hepatol. 2025 Oct 1;37(10):1141-1146. doi: 10.1097/MEG.0000000000002985. Epub 2025 Apr 29.
- Individual participant dataSharing planned: No
Related trials for Proton Pump Inhibitor Adverse Reaction
Recruiting
Lactobacillus Reuteri Strain Combination in Children Treated With PPI
Gastric Lesion, Proton Pump Inhibitor Adverse Reaction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gasser I El-Azab, M.D. principal investigator
National Liver Institute, Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proton Pump Inhibitor Adverse Reaction and Liver Cirrhosis, run by National Liver Institute, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inappropriate use of PPIs (time frame: Six weeks after study completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06384443, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.