Effect of Simethicone on Helicobacter Pylori Detection in Routine Endoscopy

Официальное название

Effect of Simethicone on Helicobacter Pylori Detection: A Paired, Randomized, Pilot Study in Routine Endoscopic Practice

Обзор

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.

Вмешательства

• Процедура Simeticone
  If the initial RUT (Rapid Urease Test) is positive, the patient receives 200 mL of oral simethicone (4 mg/mL). The preparation is: Each simethicone bottle contains 40 mg/mL in 10 mL volume (400 mg total per bottle). To prepare 1 litre of 4 mg/mL solution: we will take a 1 litre bottle of sterile water, aspirate and discard 100 mL, then add 10 bottles of simethicone (100 mL total volume containing 4000 mg). This creates 1000 mL of solution with a concentration of 4 mg/mL \[8,9\] After 30-60 minu
• Процедура placebo (plain water)
  If the initial RUT is positive, the patient receives an oral placebo (200 ml water). After 30-60 minutes, a second endoscopy is performed and the same set of biopsies will be taken (pre-intervention and post-intervention biopsies)

Первичные конечные точки

• Change in H.pylori Detection Rate by Rapid Urease Test before and After simethicone administration [Срок оценки: Baseline ( prior to intervention ) and 30-60 minutes post- intervention (same day assessment during second endoscopy]

Вторичные конечные точки (1)

• Change in H.pylori Detection Rate by Histology, PCR, Culture, and Urea Breath Test before and After Simethicone or placebo [Срок оценки: Baseline (pre -intervention) and 30-60 minutes post- intervention]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Bisschops R, Areia M, Coron E, Dobru D, Kaskas B, Kuvaev R, Pech O, Ragunath K, Weusten B, Familiari P, Domagk D, Valori R, Kaminski MF, Spada C, Bretthauer M, Bennett C, Senore C, Dinis-Ribeiro M, Rutter MD. Performance measures for upper gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy. 2016 Sep;48(9):843-64. doi: 10.10 PMID 27548885
• Ahsan M, Babaei L, Gholamrezaei A, Emami MH. Simethicone for the Preparation before Esophagogastroduodenoscopy. Diagn Ther Endosc. 2011;2011:484532. doi: 10.1155/2011/484532. Epub 2011 Aug 4. PMID 21826120
• Beaufort IN, Verbeek RE, Bosman JH, Al-Toma A, Bogte A, Alvarez Herrero L, Weusten BLAM. Optimal timing of simethicone administration prior to upper endoscopy: A multicenter, single-blind, randomized controlled trial. Endosc Int Open. 2023 Oct 17;11(10):E992-E1000. doi: 10.1055/a-2157-5034. eCollection 2023 Oct. PMID 37854124

Идентификаторы

NCT: NCT07293234 · SIMPACT-HP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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