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Clinical study on dual combination of vonola fumarate and amoxicillin in the treatment of refractory Helicobacter pylori infection

Clinical study on dual combination of vonola fumarate and amoxicillin in the treatment of refractory Helicobacter pylori infection

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055125
Enrollment
Unknown
Registered
2022-01-01
Start date
2022-01-15
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Helicobacter pylori infection

Interventions

Sponsors

Changzhou Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years, no gender limit; 2. No antibiotics, bismuth agents, H2 receptor antagonists, or PPIs have been used in the past four weeks; 3. 13C urea breath test is positive; 4. Agree to undergo gastroscopy to take gastric mucosal biopsy tissue samples for H.pylori culture; 5. Have at least one history of Helicobacter pylori treatment failure in the past, and be willing to cooperate with doctors to conduct follow-up investigations on the efficacy of eradication.

Exclusion criteria

Exclusion criteria: 1. Severe heart, liver and kidney damage; 2. Pregnant or lactating patients; 3. Previous history of upper gastrointestinal surgery, gastric cancer or pyloric stenosis; 4. Participated in other drug research within 3 months before using the study drug; 5. Patients cannot express their main complaints correctly, such as mental illness, severe neurosis; 6. Patients with contraindications to gastric mucosal biopsy (coagulation disorders, taking anticoagulants, etc.); 7. The patient is taking non-steroidal anti-inflammatory drugs or alcoholism at the same time; 8. The patient is allergic to any of the dual therapy for eradication of Helicobacter pylori (Vonolax fumarate tablets, Amoxicil).

Design outcomes

Primary

MeasureTime frame
eradication rate;

Secondary

MeasureTime frame
compliance;adverse reactions;Helicobacter pylori drug sensitive;

Countries

China

Contacts

Public ContactWang Xiaoyong

Changzhou Second People's Hospital

wxy20009@126.com+86 13775051593

Outcome results

None listed

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