Clinical trial · Observational
Fundic Gland Polyps and Proton Pump Inhibitor (PPI) Drugs
Determination of a Possible Association of Fundic Gland Polyps With the Use of Proton Pump Inhibitor Drugs
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor Enrollment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fundic Gland Polyps | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Fundic Gland Polyps on PPI
- description
- Patients found to have fundic gland polyps on endoscopic evaluation that have also been prescribed and regularly take a proton pump inhibitor.
- label
- Fundic Gland Polyp not on PPI
- description
- Patients found to have fundic gland polyps on endoscopic evaluation that have not been prescribed a proton pump inhibitor.
- label
- Group 3 (Control Group)
- description
- Individuals who are prescribed proton pump inhibitor but are not found to have fundic gland polyps on endoscopic evaluation.
Primary outcomes (1)
- measure
- Number of patients with fundic gland polyps and PPI use that have a higher gastric pH
- timeFrame
- Up to 1 year
- description
- We 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. We believe there is a correlation between fundic gland polyps of the stomach and use of proton pump inhibiter medications.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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. Exclusion Criteria: * Unwilling or unable to sign informed consent for the study.
References
Publications (0)
Data not yet available