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Effect of Simethicone on Helicobacter Pylori Detection in Routine Endoscopy

NCT07293234 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-01-02

No results posted yet for this study

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: 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.

Conditions

  • H Pylori Infection

Interventions

PROCEDURE

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 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).

PROCEDURE

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)

Sponsors & Collaborators

  • Asian Institute of Gastroenterology, India

    lead OTHER

Principal Investigators

  • Dr.Mohan Kumar Ramchandani, MD, DM · AIG Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-05-31
Completion
2026-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07293234 on ClinicalTrials.gov