Health Condition 1: B968- Other specified bacterial agents as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Saveetha medical college and hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1)Individuals aged 18 years and above. 2)Patients presenting with gastrointestinal symptoms suggestive of Helicobacter pylori infection (e.g., upper abdominal pain, bloating, nausea). 3)Patients who are willing and able to provide informed consent. 4)Participants willing to undergo both the smart breath analyzer test and standard diagnostic procedures for H. pylori.
Exclusion criteria
Exclusion criteria: 1)Patients who have taken antibiotics, proton pump inhibitors (PPIs), or bismuth compounds within the last 4 weeks. 2)History of gastrectomy or major gastrointestinal surgery. 3)Pregnant or breastfeeding women. 4)Patients with severe respiratory conditions (e.g., COPD) that may interfere with breath sampling. 5)Individuals with known allergies to the urea test substrate. 6)Patients unable to comply with study procedures or follow-up. 7)Cognitively impaired individuals unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To develop and evaluate a novel smart breath analyzer capable of accurately detecting Helicobacter pylori infection by measuring urease activity in exhaled breath, offering a non-invasive, rapid, and user-friendly diagnostic alternative to conventional methods. Timepoint: Day 0 | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the diagnostic accuracy (sensitivity, specificity, PPV, NPV) of the smart breath analyzer with the standard urea breath test and/or endoscopic biopsy-based methods. To assess the usability and patient compliance associated with the smart breath analyzer in clinical and outpatient settings. To evaluate the real-time data processing and interpretation capabilities of the device s integrated smart interface. Timepoint: Day 0, day 2 | — |
Countries
India
Contacts
Public ContactGUNDETI THARUN REDDY
Saveetha medical college and hospital
Outcome results
None listed