Skip to content

Clinical trial of rapid test paper (chemical reaction method) for Helicobacter pylori

Clinical trial of rapid test paper (chemical reaction method) for Helicobacter pylori - Medical category

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500097395
Enrollment
Unknown
Registered
2025-02-19
Start date
2023-02-22
Completion date
Unknown
Last updated
2025-02-24

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

Conditions

Helicobacter pylori infection of stomach

Interventions

Index test:Positive coincidence rate, negative coincidence rate, total coincidence rate and 95% confidence interval
Kappa consistency analysis.

Sponsors

Jiangmen Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Subjects enter the UBT project test based on their own clinical needs and voluntarily sign a letter of understanding, including factors such as different ages and gender; Adequate sample size (coating and / or tartar approximately 1 mm in diameter); Complete and clear information about the subject and the specimen (traceability, age, gender, clinical diagnosis, etc.) Samples were collected and processed in accordance with the reagent instructions or relevant regulations. 2. Positive group: collecting clinical symptoms of digestive system, including (but not limited to) gastritis, peptic ulcer (gastric ulcer, Twelve finger ulcers), gastric mucosal atrophy / erosion, acid reflux, heartburn and stomachache, halitosis, etc. According to previous case reports, Helicobacter pylori may be positive and meet the requirements of 1; 3. Negative group: collect clinical non-positive group symptoms and healthy people and meet the requirements of 1.

Exclusion criteria

Exclusion criteria: 1. Poor compliance (unmatched sample collection); 2. does not meet the eligibility criteria; 3. Tuberculosis of intestine; 4. Use of proton pump inhibitors and H2 receptor antagonists within 2 weeks; 5. The investigator believes that the sample does not meet the test requirements (the sample is contaminated or the sample storage process does not comply with the reagent instructions).

Design outcomes

Primary

MeasureTime frame
Positive coincidence rate;Negative coincidence rate;Total compliance rate;

Countries

China

Contacts

Public ContactZhao Jinglin

Jiangmen Central Hospital

403612238@qq.com+86 139 0288 1238

Outcome results

None listed

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