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High-dose dual therapy for treatment-naive patients of H. pylori infection: a prospective, multicenter, randomized controlled trial in Hubei

High-dose dual therapy for treatment-naive patients of H. pylori infection: a prospective, multicenter, randomized controlled trial in Hubei

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033966
Enrollment
Unknown
Registered
2020-06-19
Start date
2020-07-01
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

H.pylori

Interventions

Dual therapy group:Esomeprazole 20 mg, and amoxicillin 750 mg
4 times a day (among them, 16 units use amoxicillin 1000mg, 3 times a day). The group receives the regime for 14 days.
Quadruple therapy group:Esomeprazole 20 mg, bismuth potassium citrate 220 mg, amoxicillin 1000 mg, and clarithromycin 500mg
twice a day.The group receives the regime for 14 days.

Sponsors

Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients, aged between 18-65 years; 2. Patients diagnosed as HP infection by C13 / C14 urea breath test or immunohistochemical staining of biopsy samples; 3. Patients with indications of HP eradication and no antagonistic factors; 4. Patients who have not received HP eradication treatment before; 5. Patients who did not take antibiotics, bismuth and antibacterial traditional Chinese medicine 4 weeks before the treatment, and those who did not take PPI, H2 receptor antagonists and other drugs that affect the activity of HP 2 weeks before the treatment; 6. Patients were informed and agreed to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Patients with severe heart, liver, lung and kidney dysfunction and low immunity; 2. Patients with penicillin or program related drug allergy contraindications; 3. Patients with mental illness and communication disorder; 4. Pregnant and lactating patients; 5. Patients with organic diseases such as gastrointestinal tumor and gastrointestinal hemorrhage; 6. Patients who are participating in other clinical trials; 7. The researchers think it is not suitable for the patients.

Design outcomes

Primary

MeasureTime frame
The eradication rate of Helicobacter pylori;

Secondary

MeasureTime frame
adverse events;patient adherence;Cost of drug;

Countries

China

Contacts

Public ContactPeiyuan Li

Department of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of science and technology

pyli@tjh.tjmu.edu.cn+86 13317171760

Outcome results

None listed

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