Effect of Simethicone on Helicobacter Pylori Detection in Routine Endoscopy

Asian Institute of Gastroenterology, India

Status: Not yet enrolling

Conditions: H Pylori Infection

Treatments: Procedure: Simeticone; Procedure: placebo (plain water)

Study type: Interventional

Funder types: Other

Identifiers

NCT07293234

SIMPACT-HP

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 19 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Age ≥18 years and <80 years
• Rapid Urease Test (RUT) positive on endoscopic gastric biopsy
• Ability to provide informed consent

Exclusion Criteria

• 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
• Current anticoagulation therapy
• Severe thrombocytopenia (platelet count <50,000/mm³)
• Severe comorbidities that contraindicate the administration of sedation
• Immunodeficiency
• Pregnancy
• Negative initial Rapid Urease Test (RUT)
• Inability to provide informed consent

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups, including a placebo group

Arm A (Simethicone Group)

Experimental group

Treatment:

Procedure: Simeticone

Arm B (Placebo Group)

Placebo Comparator group

Treatment:

Procedure: placebo (plain water)