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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045059
Enrollment
Unknown
Registered
2021-04-04
Start date
2021-04-01
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

Control group: Esomeprazole 20mg qid + Amoxicillin 750mg qid
Test group 1:Esomeprazole 40mg bid + Amoxicillin 1000mg tid
Test group 2:Esomeprazole 20mg tid + Amoxicillin 1000mg tid

Sponsors

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
Helicobacter pylori eradication rate;

Secondary

MeasureTime frame
Adverse events;Compliance;

Countries

China

Contacts

Public ContactLi Peiyuan

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

pyli@tjh.tjmu.edu.cn+86 27 83663661

Outcome results

None listed

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