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Multicenter Epidemiological Survey of Helicobacter pylori Antibiotic Resistance in China and Clinical Study on Individualized Eradication Therapy Guided by Susceptibility Test

Multicenter Epidemiological Survey of Helicobacter pylori Antibiotic Resistance in China and Clinical Study on Individualized Eradication Therapy Guided by Susceptibility Test

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089401
Enrollment
Unknown
Registered
2024-09-08
Start date
2024-09-18
Completion date
Unknown
Last updated
2024-09-16

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 (group of susceptibility-guided therapy):Bismuth quadruple treatment containing sensitive antibiotics according to the result of drug resistance test
Control group (group of empirical therapy):Bismuth quadruple treatment containing antibiotics that haven't been used before according to medical history
Observation group:None

Sponsors

Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Sub-study (1) ? Age between 18 and 70; ? Patients who intend to undergo gastroscopy in the hospital; ? Urea breath test (+); ? Agree to participate in this clinical study and sign the informed consent form. Sub-study (2) ? Age between 18 and 70; ? Confirmed H. pylori infection, with =2 of the following 4 tests positive: a. Urea breath test; b. Rapid urease test; c. Staining of gastric mucosal tissues; d. H. pylori culture; ? Agree to participate in this clinical trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: Sub-study (1) ? Pregnant or lactating women and patients with mental illness; ? Use of PPIs and P-CABs in the past 2 weeks and antibiotics, bismuth and herbal medicines with antimicrobial effect in the past 4 weeks; ? Previous history of gastric surgery; ? Severe organic diseases of the digestive system, such as malignant tumour of the digestive tract, gastrointestinal bleeding, peptic ulcer with perforation/obstruction, intestinal obstruction, inflammatory bowel disease; ? Severe systemic diseases, such as severe cardiovascular and cerebrovascular diseases, diabetes mellitus, chronic renal insufficiency, connective tissue disease, neurological lesions, etc; ? Any other factors that, in the opinion of the investigator, make the subject unsuitable for enrolment or affect the subject's participation in the study. Sub-study (2) ? Pregnant or lactating women and patients with recent birth plans; ? People with disabilities stipulated by law (blindness, deafness, dumbness, mental disorder, mental disorder, physical disability); ? Those who are allergic to experimental drugs (amoxicillin, clarithromycin, metronidazole, levofloxacin, tetracycline, PPI, bismuth); ? Need for continuous use of adrenocortical steroids, non-steroidal anti-inflammatory drugs and anticoagulants; ? Previous history of gastric surgery; ? Use of PPIs and P-CABs in the past 2 weeks and antibiotics, bismuth and herbal medicines with antimicrobial effect in the past 4 weeks; ? Suspected or confirmed history of alcohol and drug abuse. ? Severe organic diseases of the digestive system, such as malignant tumour of the digestive tract, gastrointestinal bleeding, peptic ulcer with perforation/obstruction, intestinal obstruction, inflammatory bowel disease; ? Severe systemic diseases, such as severe cardiovascular and cerebrovascular diseases, diabetes mellitus, chronic renal insufficiency, connective tissue disease, neurological lesions, etc; ? Any other factors that, in the opinion of the investigator, make the subject unsuitable for enrolment or affect the subject's participation in the study.

Design outcomes

Primary

MeasureTime frame
H. pylori resistance rate;H. pylori eradiction rate;

Secondary

MeasureTime frame
subject compliance;

Countries

China

Contacts

Public ContactYiqi Du

Changhai Hospital

duyiqi@hotmail.com+86 138 0199 3592

Outcome results

None listed

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