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Accuracy analysis of rapid diagnosis and drug sensitivity test for Helicobacter pylori via capsule sampling line

Accuracy analysis of rapid diagnosis and drug sensitivity test for Helicobacter pylori via capsule sampling line

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000041585
Enrollment
Unknown
Registered
2020-12-31
Start date
2020-09-01
Completion date
Unknown
Last updated
2021-03-22

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:Bacterial culture for Helicobacter pylori
Index test:qPCR&#32
test&#32
after&#32
taking&#32
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line.

Sponsors

Shenzhen Kuichong People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Subjects aged 18-70 years; 2. Healthy physical examinees who come to the Department of Gastroenterology of Kwai Chung Hospital for diagnosis and treatment and sign informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. Subjects who had previously received treatment for Helicobacter pylori infection; 2. Subjects who had received proton pump inhibitors, H2 receptor antagonists, expectorants or antibiotics within four weeks before endoscopy; 3. Patients who have a history of gastric surgery or have been diagnosed with gastrointestinal cancer; 4. Patients with serious heart, lung, liver, kidney or blood system diseases.

Design outcomes

Primary

MeasureTime frame
SEN, SPE, ACC, AUC of ROC;

Countries

China

Contacts

Public ContactYongsheng He

Shenzhen Kuichong People's Hospital

1933418841@qq.com+86 13556862190

Outcome results

None listed

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