Helicobacter Pylori Eradication With Different Bismuth Quadruple Therapies

• Status: Completed
• Trial end date: 2020-08-30
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to compare efficacy and safety of bismuth-containing quadruple therapy（with rabeprazole amoxicillin clarithromycin）of different kinds of bismuth（Bismuth potassium citrate, pectin bismuth capsules, pectin bismuth particles）in H. pylori first-line eradication. It is hypothesized that different bismuth containing quadruple therapies have comparable eradication efficacy and safety. Patients with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 2and 6 follow-up visits, a urea breath test(UBT) will be performed to confirm eradication.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xijing Hospital of Digestive Diseases
• Treatments: Amoxicillin; Bismuth; Citric Acid; Clarithromycin; Potassium Citrate; Rabeprazole; Sodium Citrate

Criteria

Inclusion Criteria:

• Age between 18~75,both gender.

• Patients with upper gastrointestinal symptoms and with documented H.pylori infection.

• Patients are willing to receive eradication treatment.

• Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter.

Exclusion Criteria:

• Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.

• Contraindications to study drugs.

• Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease.

• Constant use of anti-ulcer drugs ( including taking proton-pump.inhibitors(PPI) within 2 weeks before the [13C] urea breath test),antibiotics or bismuth complexes (more than 3 times /1 month before screening).

• Patients were diagnosed with gastroduodenal ulcer and MALTlymphoma.

• Pregnant or lactating women.

• Underwent upper gastrointestinal Surgery.

• Patients with Barrett esophageal or highly atypical hyperplasia, have symptom of dysphagia.

• Evidence of bleeding or iron efficiency anemia.- Page 3 of 4 [DRAFT] -

• A history of malignancy.

• Drug or alcohol abuse history in the past 1 year.

• Systemic use of corticosteroids, non steroidal anti-inflammatory drugs,anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).

• Patients who has psychological problem or poor compliance.

• Enrolled in other clinical trials in the past 3 months.

• Refuse to sign informed consent.