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Clinical Trial of Helicobacter Pylori Antibody (Oral Mucosal Exudate) Detection Kit (Colloidal Gold Method)

Clinical Trial of Helicobacter Pylori Antibody (Oral Mucosal Exudate) Detection Kit (Colloidal Gold Method)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600118176
Enrollment
Unknown
Registered
2026-02-03
Start date
2024-03-05
Completion date
Unknown
Last updated
2026-02-09

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:urea breath test(UBT)
Index test:Helicobacter Pylori Antibody (Oral Mucosal Exudate) Detection Kit (Colloidal Gold Method)

Sponsors

ShanghaiTongji Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 81 Years

Inclusion criteria

Inclusion criteria: (1) The subjects shall include populations with symptoms such as gastritis, peptic ulcer and dyspepsia, as well as some asymptomatic populations with clinical suspicion of Helicobacter pylori (H. pylori) infection (e.g., health check-up populations). (2) The subjects shall be able to collect an adequate amount of samples as required. (3) The participants shall cover different age groups and genders. (4) The participants shall be populations who have completed or are about to undergo UBT (Urea Breath Test).

Exclusion criteria

Exclusion criteria: (1) Populations who have received Helicobacter pylori (H. pylori) eradication therapy (2) Cases with unclear sampling time or information, without serum/plasma and breath test results, or with missing clinical data (3) Samples that do not meet the sampling requirements (4) Obviously contaminated samples (5) Samples that are deemed unqualified for testing by researchers.

Design outcomes

Primary

MeasureTime frame
Positive Concordance Rate;Negative Concordance Rate;Overall Concordance Rate;Kappa Coefficient;Sensitivity;Specificity;

Countries

China

Contacts

Public ContactShuchang Xu

Shanghai Tongji Hospital

xschang@163.com+86 136 0199 9711

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026