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Effectiveness and Safety Evaluation of Treatment Regimen for Helicobacter pylori Infection Including Levofloxacin: A Prospective, Randomized Controlled Study

Effectiveness and Safety Evaluation of Treatment Regimen for Helicobacter pylori Infection Including Levofloxacin: A Prospective, Randomized Controlled Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088791
Enrollment
Unknown
Registered
2024-08-27
Start date
2024-08-28
Completion date
Unknown
Last updated
2024-09-02

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

Conditions

Helicobector pylori

Interventions

Levofloxacin-based dual therapy group.:Levofloxacin 50mg per dose, twice a day, orally taken half an hour before breakfast and dinner
Amoxicillin capsules 1000mg per dose, three times a day, orally taken half an hour after breakfast, lunch, and dinner. Oral administration for 14 days.
Bismuth-based quadruple therapy group.:Lansoprazole 30mg per dose, twice a day, orally taken half an hour before breakfast and dinner
Bismuth potassium citrate capsules 240mg per dose, twice a day, orally taken half an hour before breakfast and dinner
Clarithromycin tablets 500mg per dose, twice a day, orally taken half an hour after breakfast and dinner
Amoxicillin capsules 1000mg per dose, twice a day, orally taken half an hour after breakfast and dinner.

Sponsors

The First Affiliated Hospital of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 69 Years

Inclusion criteria

Inclusion criteria: 1.Aged between 18 and 69 years old; 2. Individuals with a positive result in the 13C or 14C breath test, or confirmed as Helicobacter pylori infection through at least two of the following methods: rapid urease test, histopathology, Hp culture, and fecal Hp antigen test; 3. Have not received eradication therapy for Helicobacter pylori in the past; 4. Willing to undergo anti-Hp treatment and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1.Individuals allergic to any investigational drug; 2. Individuals who have undergone partial or total gastrectomy; 3. Individuals with significant organ dysfunction such as respiratory, cardiac, hepatic, renal insufficiency, etc.; 4. Individuals who have used antibiotics or corticosteroids within 4 weeks prior to enrollment, or acid suppressants within 2 weeks prior to enrollment; 5. Pregnant or lactating women; 6. Individuals who are unwilling to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
13C-UBT;

Secondary

MeasureTime frame
compliance;

Countries

China

Contacts

Public ContactJi Li

The First Affiliated Hospital of Xiamen University

492264624@qq.com+86 138 6046 7759

Outcome results

None listed

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