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Accuracy of 45mg urea breath test kit in diagnosis of Helicobacter pylori infection in adults

Accuracy of low dose 13C-urea breath test in diagnosis of Helicobacter pylori infection in adults

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400090596
Enrollment
Unknown
Registered
2024-10-09
Start date
2023-10-10
Completion date
Unknown
Last updated
2024-10-15

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:75mg breath test
Index test:45mg breath test

Sponsors

Shenzhen Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Subjects aged 18-75 years with or without digestive symptoms;Those who agreed to participate in the clinical trial and provided written informed consent.

Exclusion criteria

Exclusion criteria: (1) Acid suppressants such as PPI and H2 receptor antagonists were taken within 2 weeks, and antibiotics, bismuth, and traditional Chinese medicine with antibacterial effects were taken within 4 weeks. (2) Upper gastrointestinal bleeding within one week (3) partial gastrectomy (4) patients with severe underlying diseases or severe surgical history who could not tolerate breath test examination (5) patients who had participated in clinical trials of other drugs or devices within 3 months before enrollment (6) other conditions considered by the investigator to be not suitable for participation in the trial

Design outcomes

Primary

MeasureTime frame
Kappa value was used for consistency evaluation;

Countries

China

Contacts

Public ContactChen Ye

Shenzhen Hospital of Southern Medical University

chenye2001@hotmail.com+86 139 2229 3223

Outcome results

None listed

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