Helicobacter Pylori Eradication With Different Bismuth Quadruple Therapies

Xijing Hospital of Digestive Diseases

Status and phase: Completed; Phase 4

Conditions: Gastric Cancer; Helicobacter Pylori Infection; Bismuth

Treatments: Drug: Bismuth potassium citrate containing quadruple therapy; Drug: Colloidal pectin bismuth particles B quadruple therapy; Drug: Colloidal pectin bismuth capsules containing quadruple therapy; Drug: Colloidal pectin bismuth particles A quadruple therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04209933

KY20192146-C-1

Details and patient eligibility

About

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.

Full description

The study will include three phases: screening, treatment and follow-up.Screening: this phase will last a maximum of 28 days and subjects eligibility will be evaluated after informed consent signature. Endoscopy and Urea Breath test will be performed in addition to the baseline routine evaluations.Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 12 and 14.Follow-up: includes two visits. approximately 14 days of treatment and 28 days after the end of treatment. Eradication of H. Pylori will be confirmed through urea breath test(UBT).

Enrollment: 240 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

240 participants in 4 patient groups

Bismuth potassium citrate containing quadruple therapy

Active Comparator group

Description:

Bismuth potassium citrate 220 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.

Treatment:

Drug: Colloidal pectin bismuth particles A quadruple therapy

Drug: Bismuth potassium citrate containing quadruple therapy

Drug: Colloidal pectin bismuth particles B quadruple therapy

Drug: Colloidal pectin bismuth capsules containing quadruple therapy

Colloidal pectin bismuth capsules containing quadruple therapy

Active Comparator group

Description:

Colloidal pectin bismuth capsules 200 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.

Treatment:

Drug: Colloidal pectin bismuth particles A quadruple therapy

Drug: Bismuth potassium citrate containing quadruple therapy

Drug: Colloidal pectin bismuth particles B quadruple therapy

Drug: Colloidal pectin bismuth capsules containing quadruple therapy

Colloidal pectin bismuth particles A quadruple therapy

Active Comparator group

Description:

Colloidal pectin bismuth particles 150 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.

Treatment:

Drug: Colloidal pectin bismuth particles A quadruple therapy

Drug: Bismuth potassium citrate containing quadruple therapy

Drug: Colloidal pectin bismuth particles B quadruple therapy

Drug: Colloidal pectin bismuth capsules containing quadruple therapy

Colloidal pectin bismuth particles B quadruple therapy

Active Comparator group

Description:

Colloidal pectin bismuth particles 300 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.

Treatment:

Drug: Colloidal pectin bismuth particles A quadruple therapy

Drug: Bismuth potassium citrate containing quadruple therapy

Drug: Colloidal pectin bismuth particles B quadruple therapy

Drug: Colloidal pectin bismuth capsules containing quadruple therapy