Rationale: Although simethicone improves mucosal clarity, in vitro evidence suggests that its surfactant properties may disrupt bacterial adherence or viability. These findings raise concerns that simethicone may negatively affect the sensitivity of endoscopic-based H. pylori diagnostic methods. To date, no prospective in vivo study has evaluated whether simethicone influences H. pylori detection through endoscopic sampling. This randomized paired trial is designed to address this gap in evidence and evaluate whether simethicone administration reduces diagnostic yield.
Hypothesis: Simethicone administration prior to upper gastrointestinal endoscopy may reduce the detection rate of H. pylori by interfering with bacterial detection and diagnostic test performance.
Note on Pilot Study Design: This is a pilot study conducted to test feasibility and inform the design of a larger future trial.
Objectives:
To evaluate whether oral administration of simethicone prior to endoscopy reduces the diagnostic yield of H. pylori using the rapid urease test (RUT).
To evaluate whether oral administration of simethicone impacts the detection of H. pylori by other diagnostic methods, including histology, PCR, culture, and urea breath testing performed during endoscopy.
To explore variability in detection methods and determine feasibility for a future larger trial.
Age ≥18 years and <80 years
Rapid Urease Test (RUT) positive on endoscopic gastric biopsy
Ability to provide informed consent
Use of antibiotics or bismuth compounds within 4 weeks prior to enrollment
Use of proton pump inhibitors (PPIs) within 2 weeks prior to enrollment
Use of H2 receptor blockers within 72 hours prior to enrollment
History of previous gastric surgery