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Evaluation of the efficacy of susceptibility-guided triple therapy versus empiric amoxicillin and clarithromycin-containing bismuth quadruple therapy for first-line Helicobacter pylori treatment: a multicenter randomized controlled clinical study

Evaluation of the efficacy of susceptibility-guided triple therapy versus empiric amoxicillin and clarithromycin-containing bismuth quadruple therapy for first-line Helicobacter pylori treatment: a multicenter randomized controlled clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083150
Enrollment
Unknown
Registered
2024-04-16
Start date
2023-03-01
Completion date
Unknown
Last updated
2024-04-22

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:susceptibility-guided triple therapy
control group:empiric amoxicillin and clarithromycin-containing bismuth quadruple therapy

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged from 18 to 65 years, male or female 2. 13C urea breath test was positiveThose with gastrointestinal symptoms or age >35 years who require gastroscopy and are judged by a physician to require eradication of Hp ( eradication is recommended without countervailing factors) 3. No previous helicobacter pylori eradication treatment 4. Signed informed consent

Exclusion criteria

Exclusion criteria: 1.Drugs that may affect the study results, such as PPI, H2 receptor antagonists, bismuth, antibiotics or traditional Chinese medicine(Jinghua WeikangGanhai Weikang) with H. pylori inhibitory effect, were taken within 4 weeks before enrollment 2. PCR test showed negative Hp infection 3.Pregnant or breastfeeding women 4. Patients with malignant tumors of digestive tract 5. Patients with a history of gastric or esophageal surgery 6. Allergies to therapeutic drugs 7. Concomitant with severe cardiovascular and cerebrovascular diseases, liver and kidney diseases, hematopoietic system diseases, and mental illnesses 8. Other situations that the doctor deems unsuitable for enrollment

Design outcomes

Primary

MeasureTime frame
H. pylori eradication rate;

Secondary

MeasureTime frame
The resistance rate of Helicobacter pylori to clarithromycin and levofloxacin;Adverse Events ;

Countries

China

Contacts

Public ContactWang Weihong

Peking University First Hospital

wangweihong2581@163.com+86 130 4117 1610

Outcome results

None listed

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