Effect of Simethicone on Helicobacter Pylori Detection: A Paired, Randomized, Pilot Study in Routine Endoscopic Practice
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Change in H.pylori Detection Rate by Rapid Urease Test before and After simethicone administration
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years and <80 years
- •Rapid Urease Test (RUT) positive on endoscopic gastric biopsy
- •Ability to provide informed consent
排除标准
- •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
结局指标
主要结局
Change in H.pylori Detection Rate by Rapid Urease Test before and After simethicone administration
时间窗: Baseline ( prior to intervention ) and 30-60 minutes post- intervention (same day assessment during second endoscopy
次要结局
- Change in H.pylori Detection Rate by Histology, PCR, Culture, and Urea Breath Test before and After Simethicone or placebo(Baseline (pre -intervention) and 30-60 minutes post- intervention)
研究者
Mohan Ramchandani
MD, DM, FJGES , Director interventional Endoscopy , senior consultant Gastroenterologist
Asian Institute of Gastroenterology, India