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A prospective multicenter, randomized, open, two-stage clinical study on the efficacy of high-dose dual therapy containing amoxicillin for eradication of Helicobacter pylori

A prospective multicenter, randomized, open, two-stage clinical study on the efficacy of high-dose high-dose dual therapy containing amoxicillin for eradication of Helicobacter pylori

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045778
Enrollment
Unknown
Registered
2021-04-24
Start date
2021-04-26
Completion date
Unknown
Last updated
2021-12-06

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

Conditions

Helicobacter pylori infection

Interventions

group A:amoxicillin (1000mg twice A day)+ clarithromycin (500mg twice A day)+ bismuth (220mg twice A day)+ esomeprazole (20mg twice A day) for 2 weeks
group B:Group B:amoxicillin (1000mg, 3 times a day) + vonoprazan (20mg , twice a day) for 1 weeks.
group C:amoxicillin (1000mg, 3 times a day) + vonoprazan (20mg , twice a day) for 10 days.
group D:amoxicillin (1000mg, 3 times a day) + vonoprazan (20mg , once a day) for 2 weeks.
group E:amoxicillin (1000mg, 3 times a day) + esomeprazole (40mg, twice a day) for 2 weeks.
group F:amoxicillin (1000mg, twice a day)+ clarithromycin (500mg, twice a day)+ bismuth (220mg, twice a day)+ vonoprazan (20mg, once a day) for 2 weeks.

Sponsors

Fujian Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Adult patients, aged 18 to 70 years; 2.Patients who did not take antibiotics, bismuth and traditional Chinese medicine 4 weeks before treatment, and patients who took PPI, H2 receptor antagonists and other drugs 2 weeks before treatment; 3.Hp-positive was diagnosed by C13 or C14-urea breath test and rapid urease test 4.Informed and agreed to participate in the study, patients with complete medical records and follow-up records.

Exclusion criteria

Exclusion criteria: 1.With severe heart, lung, and kidney dysfunction and low immunity; 2.Patients with drug allergy contraindications; 3.Persons with mental illness or communication difficulties; 4.Pregnancy, lactation; 5.Patients with organic diseases such as gastrointestinal tumor and gastrointestinal hemorrhage.

Design outcomes

Primary

MeasureTime frame
eradication rate;

Secondary

MeasureTime frame
adverse reaction;antibiotic resistance of Helicobacter pylori;flora;Degree of clinical symptom remission;

Countries

China

Contacts

Public ContactLin Zhihui

Fujian Provincial Hospital

303622465@qq.com+86 13799371368

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026