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Effect of Simethicone on Helicobacter Pylori Detection in Routine Endoscopy

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated January 2, 2026 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Interventions: Simeticone (Procedure) to Simeticone (Procedure), placebo (plain water) (Procedure)
    • Eligibility criteria expanded, about 27 words
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07293234
Lead Sponsor Asian Institute of Gastroenterology, India
Conditions
(from sponsor)
H Pylori Infection
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov