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Clinical consistency evaluation of a novel molecular diagnostic method for detecting antimicrobial resistance in Helicobacter pylori in gastric fluid samples

Clinical consistency evaluation of a novel molecular diagnostic method for detecting antimicrobial resistance in Helicobacter pylori in gastric fluid samples

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500098649
Enrollment
Unknown
Registered
2025-03-12
Start date
2025-03-20
Completion date
Unknown
Last updated
2025-03-17

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

Conditions

Helicobacter pylori gastritis

Interventions

Gold Standard:Hp culture drug sensitivity and generation sequencing test results
Index test:Kappa testing

Sponsors

NanJing First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age 18-65, male and female; 2.Voluntarily participated in this trial and signed an informed consent form; 3.Request to undergo upper gastrointestinal endoscopy with Hp culture; 4.Patients with urea breath test or urease test suggestive of Hp infection, or positive culture of gastric mucosal tissue for Hp;

Exclusion criteria

Exclusion criteria: 1.Withdrawal of informed consent; 2.Refusal of upper gastrointestinal endoscopy; 3.pregnancy; 4.Other factors were considered by the researcher to be unsuitable for enrolment;

Design outcomes

Primary

MeasureTime frame
Kappa coefficient consistency test;

Countries

China

Contacts

Public ContactZhang Zhenyu

NanJing First Hospital

zzy6565@sina.com+86 25 52271000

Outcome results

None listed

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