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High-sensitivity and accurate detection of Helicobacter pylori in the human stomach via the mid-infrared laser spectrometer

High-sensitivity and accurate detection of Helicobacter pylori in the human stomach via the mid-infrared laser spectrometer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300069514
Enrollment
Unknown
Registered
2023-03-20
Start date
2023-03-20
Completion date
Unknown
Last updated
2023-05-29

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:Histopathological tests
Index test:the novel 13C mid-infrared laser spectrometer detection

Sponsors

Shenzhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Age 40-70 years old, gender is not limited; (2) Patients had not received H. pylori eradication therapy before the enrollment; (3) We were able to obtain the general information of patients. We could record age, gender, lifestyle, antibiotic use, family history of their H. pylori infection and other diseases; (4) Patients were willing to sign informed consent forms, and all participants were informed and consenting.

Exclusion criteria

Exclusion criteria: (1) Patients had received proton pump inhibitors, H2 receptor antagonists, bismuth, and antibiotics within 4 weeks before enrollment; (2) Patients had a malignant tumor of the digestive system; (3) Patient had received gastrointestinal surgery; (4) Patient suffered from serious heart, lung, blood system diseases or severe liver and kidney insufficiency.

Design outcomes

Primary

MeasureTime frame
C13 Urea Breath test;Detecting Hp via the Histopathological tests;sensibility;specificity;accuracy;Joden index;reliability;Kappa value;

Countries

China

Contacts

Public ContactXiangyu Wang

Shenzhen Second People's Hospital

xiangyuwangsz@163.com18837152585

Outcome results

None listed

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