Fundic Gland Polyps and Proton Pump Inhibitor (PPI) Drugs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Study Completion Date

2012-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The class of proton pump inhibitor (PPI) medications such as omeprazole has proven extremely effective in the treatment and prevention of gastric and duodenal ulcers. Although the FDA approval for PPI therapy is limited to 6-8 weeks, many individuals remain on these agents for years, and human studies have suggested that long-term use of a PPI can result in enterochromaffin-like (ECL) cell hyperplasia, as well as being associated with the development of fundic-gland polyps of the stomach. These findings raise the concern of the possibility that long-term use of PPIs may predispose to the development of neuroendocrine tumors in patients. The investigators aim to examine clinical parameters, including history of PPI use and fasting gastrin levels, as well as histologic characteristics (particularly the presence of ECL-cell hyperplasia) of patients found to have fundic gland polyps during endoscopy. The investigators hypothesize that there is a correlation between fundic gland polyps of the stomach and the use of proton pump inhibiter medications.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Importance of Cytokines in Peptic Ulcer Disease: Implications for Treatment

NCT00534443

Peptic Ulcer

COMPLETED PHASE4

The Clinical Significance of Acid Rebound in Functional Dyspepsia

NCT01373970

Functional Dyspepsia

TERMINATED PHASE4

The Use of Oral Omeprazole and Intravenous Pantoprazole in Patients With Hypersecretion of Gastric Acid

NCT00001191

Gastrinoma Zollinger Ellison Syndrome

COMPLETED PHASE2

Effect of Acid Suppression Medication on Pediatric Microbiome

NCT02016820

Clostridium Difficile Infection

TERMINATED NA

Is Long-Term Proton Pump Inhibitor Use a Cause of Leaky Gut Syndrome

NCT06268834

Proton Pump Inhibitor Adverse Reaction

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fundic Gland Polyps

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fundic Gland Polyps on PPI

Patients found to have fundic gland polyps on endoscopic evaluation that have also been prescribed and regularly take a proton pump inhibitor.

No interventions assigned to this group

Fundic Gland Polyp not on PPI

Patients found to have fundic gland polyps on endoscopic evaluation that have not been prescribed a proton pump inhibitor.

No interventions assigned to this group

Group 3 (Control Group)

Individuals who are prescribed proton pump inhibitor but are not found to have fundic gland polyps on endoscopic evaluation.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 18 and above.
* Able and willing to sign informed consent.
* The patient had a gastric fundic gland polyp detected on EGD that was removed and sent to pathology or patient had no fundic gland polyps on EGD but are on PPIs and will serve as controls.