Ignite Creation Date:
2025-12-24 @ 5:37 AM
Ignite Modification Date:
2025-12-24 @ 5:37 AM
Study NCT ID:
NCT07293234
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-12-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Simethicone on Helicobacter Pylori Detection in Routine Endoscopy
Sponsor:
Asian Institute of Gastroenterology, India
Organization:
Study Overview
Official Title:
Effect of Simethicone on Helicobacter Pylori Detection: A Paired, Randomized, Pilot Study in Routine Endoscopic Practice
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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: We hypothesize that 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 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 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 Test performed during endoscopy.
To explore variability in detection methods and determine feasibility for a future larger trial.
Hypothesis: We hypothesize that 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 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 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 Test performed during endoscopy.
To explore variability in detection methods and determine feasibility for a future larger trial.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: