Skip to content

Bismuth-containing Quadruple Therapy with low-dose Tetracycline for Helicobacter pylori infection eradication: A multi-center randomized controlled trial

Bismuth-containing Quadruple Therapy with low-dose Tetracycline for Helicobacter pylori infection eradication: A multi-center randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068440
Enrollment
Unknown
Registered
2023-02-20
Start date
2023-02-20
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

Heilicobacter pylori infection

Interventions

experimental group(low dose tetracycline):Tetracycline 500 mg bid+amoxicillin 1000 mg bid+Rabeprazole 10mg bid+Bismuth potassium citrate 600mg/Colloidal bismuth pectin 200mg bid
control group(conventional dose tetracycline):Tetracycline 500 mg tid+amoxicillin 1000 mg bid+Rabeprazole 10mg bid+Bismuth potassium citrate 600mg/Colloidal bismuth pectin 200mg bid

Sponsors

Sir Run Run Shaw Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-70. 2. Patients with H.pylori infection(positive for 13C-urease breath test or gastric mucosal biopsy), who have done the gastroscopy within the last month. 3. Patients who have never received regular H. pylori eradication treatment. 4. Ability and willingness to participate in the study and to sign and give informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who have received Helicobacter pylori eradication treatment. 2. Patients who are allergic or have contradictions to the drugs for research. 3. Major systemic diseases, such as pulmonary disease, cardiovascular disease, and severe endocrine disease. 4. Continuous use of anti-ulcer drugs (more than 3 times per month), including proton pump inhibitors (PPI), antibiotics or bismuth within 2 weeks before C13-urease breath test or gastric mucosa biopsy. 5. Lactating women. 6. History of upper gastrointestinal surgery. 7. Patients who have Barrett's esophagus or high atypical hyperplasia with dysphagia symptoms. 8. History of malignant tumors. 9. History of drug or alcohol abuse in the past 1 year. 10. Systematic use of corticosteroids, non-steroidal anti-inflammatory drugs, anticoagulants, or platelet aggregation inhibitors (except for the use of aspirin with less than 100 mg/day) 11. Enrolled in other clinical trials in the past 3 months. 12. Patients with poor compliance. 13. Vulnerable groups, including those with mental disease, cognitive impairment or critical disease and juveniles, pregnant women, illiterates, etc.

Design outcomes

Primary

MeasureTime frame
Hp eradication rate;

Secondary

MeasureTime frame
Symptom remission rate;Incidence of adverse reactions;

Countries

China

Contacts

Public ContactHu Weiling

Department of Gastroenterology, Sir Run Run Shaw Hospital

huweiling@zju.edu.cn+86 13516800685

Outcome results

None listed

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