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A high-dose dual therapy for primary eradication of Helicobacter pylori in Hainan: a prospective, randomized, multicenter clinical trial

A high-dose dual therapy for primary eradication of Helicobacter pylori in Hainan: a prospective, randomized, multicenter clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046449
Enrollment
Unknown
Registered
2021-05-15
Start date
2021-02-01
Completion date
Unknown
Last updated
2022-01-04

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

Conditions

Helicobacter pylori infection

Interventions

control group:esomeprazole 20mg / time, 2 times / day + Colloidal Bismuth Pectin for Suspension 150mg / time, 3 times / day + amoxicillin 1000mg / time, 2 times / day + clarithromycin 500mg / time, 2
Experimental group: esmoprazole 20mg / time, 4 times / day + amoxicillin 1000mg / time, 3 times / day, the course of treatment was 14 days.

Sponsors

Haikou People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adult patients aged 18 to 65 years; 2. HP infection was diagnosed by C13 / C14 urea breath test or immunohistochemical staining of biopsy samples; 3. There were indications for HP eradication, but no countervailing factors; 4. No HP eradication treatment was received in the past; 5. No antibiotics, bismuth and antibacterial active Chinese medicine were taken 4 weeks before treatment, and no PPI, H2 receptor antagonist and other drugs affecting HP activity were taken 2 weeks before treatment; 6. Patients were informed and agreed to participate in this study.

Exclusion criteria

Exclusion criteria: 1. Patients with severe heart, liver, lung and kidney dysfunction and low immunity; 2. There were contraindications to penicillin or related drugs; 3. Those with mental illness and communication disorder; 4. Pregnancy and lactation; 5. The patients with organic diseases such as gastrointestinal tumor and gastrointestinal hemorrhage; 6. Those who are participating in other clinical experiments; 7. The researchers think that it is not suitable to be enrolled.

Design outcomes

Primary

MeasureTime frame
eradication rate;

Secondary

MeasureTime frame
Compliance;Adverse reactions;Treatment cost;

Countries

China

Contacts

Public ContactHuang Xiaoxi

Haikou People's Hospital

9701234@qq.com+86 18876631975

Outcome results

None listed

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