upper gastrointestinal discomfort
Conditions
Interventions
Gold Standard:C13
Index test:Novel domestic Helicobacter pylori fecal antigen detection kit (colloidal gold method)
Sponsors
Northern Jiangsu People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, regardless of gender; 2. Planned to undergo Helicobacter pylori testing due to upper gastrointestinal symptoms or voluntary screening; 3. Able to provide sufficient (>= 3 g) fresh fecal samples; 4. Willing to undergo urea breath test (UBT); 5. Have signed the written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have received bismuth preparations, antibiotics or probiotics within the past 4 weeks, or proton pump inhibitors (PPIs) / potassium-competitive acid blockers (PCABs) within the past 2 weeks; 2. Suffer from severe cardiac, hepatic or renal insufficiency, or advanced malignancy; 3. Have a history of gastric surgery; 4. Pregnant or lactating women; 5. Insufficient fecal sample volume, severe sample contamination, or improper sample storage.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic effectiveness:Sensitivity and specificity;Kappa consistency coefficient; | — |
Countries
China
Contacts
Public ContactZhou Bengang
Northern Jiangsu People's Hospital
Outcome results
None listed