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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (Simethicone Group) | Experimental |
| |
| Arm B (Placebo Group) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simeticone | Procedure | 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 minutes, a second endoscopy is performed and biopsies are taken for RUT, culture, PCR, and histology (Mention in detail the sites of the tissue acquisition). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in H.pylori Detection Rate by Rapid Urease Test before and After simethicone administration | Baseline ( prior to intervention ) and 30-60 minutes post- intervention (same day assessment during second endoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Change in H.pylori Detection Rate by Histology, PCR, Culture, and Urea Breath Test before and After Simethicone or placebo | This outcome measures the difference in detection rates of Helicobacter pylori using four additional diagnostic methods- histopathology , PCR, bacterial culture,and the urea breath test before and After administration of simethicone or placebo.The comparison will determine whether simethicone impacts these methgods similarly to RUT |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr.Aniruddha Pratap singh, MD, DM | Contact | 9004093248 | +91 | Doc.aniruddha85@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr.Mohan Kumar Ramchandani, MD, DM | AIG Hospitals | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27548885 | Result | 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: 10.1055/s-0042-113128. Epub 2016 Aug 22. No abstract available. | |
| 21826120 |
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| ID | Term |
|---|---|
| D012841 | Simethicone |
| ID | Term |
|---|---|
| D004129 | Dimethylpolysiloxanes |
| D012828 | Silicones |
| D012833 | Siloxanes |
| D017646 | Organosilicon Compounds |
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|
| placebo (plain water) | Procedure | 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) |
|
| Baseline (pre -intervention) and 30-60 minutes post- intervention |
| Result |
| 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. |
| 37854124 | Result | 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. |
| D009930 |
| Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |