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Multicenter randomized controlled study of H.rpylori eradication rate using the string test on drug resistance gene detection

Multicenter randomized controlled study of H.rpylori eradication rate using the string test on drug resistance gene detection

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082768
Enrollment
Unknown
Registered
2024-04-07
Start date
2024-04-07
Completion date
Unknown
Last updated
2024-04-08

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

Conditions

helicobacter pylori infection

Interventions

Experimental Group:Capsule sampling line combined with qPCR technology was used to detect HP drug resistance genes. According to the drug sensitivity test results, two antibiotics were selected, and a
Control group:Empirical four-drug combination therapy for HP eradication (2 antibiotics, 1 PPI, and 1 bismuth)

Sponsors

The Third People's Hospital of Zhengzhou
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Age range from 18 to 70 years old, regardless of gender. 2.Diagnosed as HP positive through breath test/gastric mucosal tissue pathology/rapid urease test. 3.Individuals with clear indications for HP eradication and voluntarily receiving initial treatment. 4.Volunteers accepting the string test. 5.Willing to use contraceptive measures during the research period. 6.Understand this study and voluntarily sign an informed consent form

Exclusion criteria

Exclusion criteria: 1.Allergic to the string test. 2.Within the past 4 weeks, have taken antibiotics, bismuth agents, traditional Chinese medicine with antibacterial effects, or proton pump inhibitors, potassium ion acid blockers, H2 receptor antagonists, and other drugs within 2 weeks. 3.With a history of major surgeries in the throat and upper gastrointestinal tract, including but not limited to Pilot I, Pilot II, total gastrectomy etc. 4.Suffering from malignant tumor of digestive tract within the past 5 years. 5.Minimally invasive surgery under gastroscopy in the past 4 weeks. 6.Taking adrenal cortex hormones, nonsteroidal anti-inflammatory drugs, and anticoagulants within the past 8 weeks. 7.Upper gastrointestinal bleeding within the past week. 8.Received clinical trials of other drugs or devices within the past 4 weeks. 9.There may be diseases or clinical conditions that may interfere with the evaluation of research and treatment, such as gastric or duodenal ulcers, liver diseases, cardiovascular diseases, lung diseases, kidney diseases, metabolic diseases. 10.With severe neurological or psychiatric disorders who are unable to cooperate with the examination. 11.Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
H. pylori eradication rate;

Secondary

MeasureTime frame
Compliance of precision medicine for HP eradication;String- test to detect HP and safety during medication (incidence of adverse events and adverse reactions);The resistance rate of HP to different antibiotics;

Countries

China

Contacts

Public ContactYiCui

The third people's hospital of Zhengzhou

shnk668@163.com+86 136 7368 1721

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026