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A randomized controlled trial of high-dose amoxicillin-containing dual therapy for eradication of triple-resistant Helicobacter pylori

A randomized controlled trial of high-dose amoxicillin-containing dual therapy for eradication of triple-resistant Helicobacter pylori

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100055008
Enrollment
Unknown
Registered
2021-12-30
Start date
2022-01-31
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

Group 1:Vonolaxen 20mg Bid + Colloidal Bismuth Pectin 0.2g Bid + Amoxicillin 1g Bid + Furazolidone 100mg tid 14 days
Group 2:Vonolaxine 20mg Bid + Colloidal Bismuth Pectin 0.2g Bid + Amoxicillin 1g Bid + Tetracycline 500mg tid 14 days
Group 3:Vonolax 20mg Bid + Amoxicillin 750mg qid 14 days

Sponsors

Jiangsu Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years, no gender limit; 2. Positive carbon 13 breath test, confirmed as Hp infection; 3. Failed at least one standard quadruple 14-day course of Helicobacter pylori in the past; 4. The antibiotic susceptibility test of Helicobacter pylori by gastroscope confirmed that metronidazole, clarithromycin and levofloxacin were all resistant; 5. Informed consent, volunteer participation.

Exclusion criteria

Exclusion criteria: 1. Have used probiotics, antibiotics, bismuth-containing drugs (such as bismuth potassium citrate capsules, etc.) within the past 4 weeks or used histamine receptor antagonists within 2 weeks before treatment (such as famotidine, ranitidine, cimetidine and other preparations) and proton pump inhibitors (such as omeprazole, lansoprazole, pantoprazole, rabeprazole, esomeprazole and other preparations); 2. Those who are allergic to the drugs used in the treatment plan: amoxicillin, clarithromycin, esomeprazole enteric-coated tablets, colloidal bismuth pectin, and polyzinc; 3. Gastroscopy excludes patients with acute upper gastrointestinal bleeding, early and advanced cancer of the upper gastrointestinal tract; 4. Pregnant or lactating patients; 5. Patients with serious primary diseases of liver, kidney, heart, brain, lung, endocrine system and hematopoietic system that cannot be effectively controlled; 6. Clinically significant liver and kidney insufficiency (transaminase greater than 1.5 times the upper limit of normal, or serum creatinine greater than the upper limit of normal); 7. Patients with malignant tumors who cannot give fully informed consent due to mental disorders; 8. Those who have participated in other clinical trials within three months before enrollment; 9. Patients judged by the investigator to be unsuitable to participate in clinical trials; other conditions judged by the investigator to be unsuitable for enrollment; 10. Furazolidone or tetracycline has been used in the previous treatment of Helicobacter pylori; 11. Antibiotic susceptibility test culture negative or any resistance to amoxicillin, furazolidone or tetracycline.

Design outcomes

Primary

MeasureTime frame
Helicobacter pylori eradication rate at the end of treatment;

Secondary

MeasureTime frame
clinical symptom remission rate;Compliance;

Countries

China

Contacts

Public ContactZhang Guoxin
fengye@njmu.edu.cn+86 13815897873

Outcome results

None listed

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