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Clinical study on consistency evaluation of H. pylori drug resistance gene testing based on gastric mucosa, gastric fluid and stool samples

Clinical study on consistency evaluation of H. pylori drug resistance gene testing based on gastric mucosa, gastric fluid and stool samples

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400084465
Enrollment
Unknown
Registered
2024-05-17
Start date
2024-05-20
Completion date
Unknown
Last updated
2024-05-21

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

Conditions

H. pylori

Interventions

stool samples group:None
gastric fluid group:None
gastric mucosa group:None

Sponsors

Civil Aviation General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Select 18-75 years (including thresholds at both ends), no gender limitation; 2) patients with 14C or 13C breath test positive for H. pylori; 3) patients who have not eradicated H pylori within the last six months; 4) subjects have fully understood the study and voluntarily signed a written informed consent.

Exclusion criteria

Exclusion criteria: 1) Those who have used proton pump inhibitors or H2 receptor antagonists, antibiotics, bismuth agents, and gastric mucosal protectors within 4 weeks before screening; 2) Previous repeated use (5 times or more times in 1 year) or long-term use (continuous use for 10 weeks or more) macrolide and penicillin drugs; 3) For the trial-related drugs, Such as bismuth agent, rabeprazole, penicillin (amoxicillin, etc.), macrolide (clarithromycin, etc.), levofloxacin, metronidazole in any component allergy or test-related drug contraindications; 4) Patients with malignant tumors or a history of esophageal and gastrointestinal surgery; 5) Patients with pyloric obstruction, gastric perforation, esophageal erosion, ulcer, esophagitis, and Zhuo-Ai syndrome; 6) Patients with acute upper gastrointestinal bleeding within the previous week before screening; 7) Drugs or NSAIDs affecting the anticoagulation system, coagulation system and fibrinolytic system are required during the trial; 8) other serious cardiac, liver and renal insufficiency, anemia and other severe hematopoietic and coagulation diseases are not effectively controlled; 9) pregnant or lactating women, or subjects with positive pregnancy examination, or birth planning within 6 months after screening examination; 10) a history of drug or alcohol abuse within 1 year before screening, or do not agree to the provisions of the trial during the study; 11) the investigator comprehensively determine that patients who are not suitable for the clinical trial.

Design outcomes

Primary

MeasureTime frame
consistency of H. pylori drug resistance gene testing ;

Secondary

MeasureTime frame
sensitivity;specificity;

Countries

China

Contacts

Public ContactJianping Cheng

Civil Aviation General Hospital

cjpczy2004@163.com+86 158 1128 2039

Outcome results

None listed

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