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Detection of Helicobacter pylori infection and antibiotic resistance based on stool and gastric mucosa

Detection of Helicobacter pylori infection and antibiotic resistance based on stool and gastric mucosa

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500096852
Enrollment
Unknown
Registered
2025-02-07
Start date
2024-01-26
Completion date
Unknown
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

helicobacter pylori infection

Interventions

Gold Standard:13C/14C urea breath test
Index test:Fecal Helicobacter pylori nucleic acid detection kit

Sponsors

Lanzhou University Second Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-85 years old, gender unlimited; 2. Helicobacter pylori 13C or 14C urea breath test or rapid urease test was performed before radical treatment, 13C or 14C urea breath test was performed after radical treatment, and Helicobacter pylori nucleic acid test of fecal specimen was performed before and after radical treatment. 3. Voluntarily participate in the project and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with antibiotics, bismuth or proton pump inhibitors within 4 weeks were excluded; 2. Exclude those with poor mental state and abnormal cognition; 3. Patients with active bleeding or gastrectomy were excluded; 4. The 14C urea breath test should exclude children, pregnant or nursing patients; 5. Patients with serious diseases of the heart, liver, lung, kidney, blood and other systems or serious malignant tumors are excluded;

Design outcomes

Primary

MeasureTime frame
The consistency between the detection of Helicobacter pylori in stool and the gold standard;

Secondary

MeasureTime frame
Sensitivity;Specificity;Antibiotic resistance rate was detected in stool;

Countries

China

Contacts

Public ContactDe-Kui Zhang

Lanzhou University Second Hospita

sczdk1972@163.com+86 139 0931 8616

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026