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Cefuroxime containing dual therapy and bismuth containing quadruple therapy for primary eradication of Helicobacter pylori infection: a prospective, multicenter, randomized controlled trial

Cefuroxime containing dual therapy and bismuth containing quadruple therapy for primary eradication of Helicobacter pylori infection: a prospective, multicenter, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071210
Enrollment
Unknown
Registered
2023-05-08
Start date
2023-05-08
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

Helicobacter pylori infection

Interventions

Control group:Cefuroxime 500mg bid + Levofloxacin 500mg qd + Vonolasan 20mg bid + Bismuth potassium citrate 220mg bid for 14 days.
Experimental group :Cefuroxime 500mg tid + Vonolasan 20mg bid for 14 days.

Sponsors

Tongji Medical College, Huazhong University of Science and Technology/ 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 18-65 years; 2. H. pylori infection was diagnosed by C13/ C14-urea breath test; 3. With H. pylori eradicating indications, without counterbalance factors; 4. Did not receive H. pylori eradication therapy; 5. No antibiotics, bismuth and antibacterial active Chinese medicine were taken 4 weeks before treatment; In the first 2 weeks, no Vonorosine, PPI or non-steroidal anti-inflammatory drugs were taken; 6. Patients were informed and consented to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Patients with severe heart, liver, lung and renal insufficiency and low immunity (such as HIV infection and moderate cancer treatment); 2. Patients with allergy contraindications of cefuroxime, levofloxacin or related drugs in the regimen; 3. Patients with mental illness or communication disorder; 4. Pregnancy and lactation; 5. Complicated with severe digestive tract diseases, such as tumors, digestive tract bleeding, and Zhuo-Ai syndrome; 6. Participating in other clinical trials; 7. Those who were considered unsuitable for inclusion by the researchers.

Design outcomes

Primary

MeasureTime frame
Helicobacter pylori eradication rate;

Secondary

MeasureTime frame
Adverse events;Compliance;

Countries

China

Contacts

Public ContactLi Peiyuan

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