Helicobacter Pylori Eradication With Different Bismuth Quadruple Therapies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-25

Study Completion Date

2020-08-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Gastric Cancer Helicobacter Pylori Infection Bismuth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bismuth potassium citrate containing quadruple therapy

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

Group Type ACTIVE_COMPARATOR

Bismuth potassium citrate containing quadruple therapy

Intervention Type DRUG

Bismuth potassium citrate:given for 14 days at a dose of bismuth potassium citrate 220 mg 0 BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID

Colloidal pectin bismuth capsules containing quadruple therapy

Intervention Type DRUG

Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth capsules 200 mg 0 BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID

Colloidal pectin bismuth particles A quadruple therapy

Intervention Type DRUG

Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth particles 150 mg BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID

Colloidal pectin bismuth particles B quadruple therapy

Intervention Type DRUG

Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth particles 300 mg BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID

Colloidal pectin bismuth capsules containing quadruple therapy

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

Group Type ACTIVE_COMPARATOR

Bismuth potassium citrate containing quadruple therapy

Intervention Type DRUG

Bismuth potassium citrate:given for 14 days at a dose of bismuth potassium citrate 220 mg 0 BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID

Colloidal pectin bismuth capsules containing quadruple therapy

Intervention Type DRUG

Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth capsules 200 mg 0 BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID

Colloidal pectin bismuth particles A quadruple therapy

Intervention Type DRUG

Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth particles 150 mg BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID

Colloidal pectin bismuth particles B quadruple therapy

Intervention Type DRUG

Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth particles 300 mg BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID

Colloidal pectin bismuth particles A quadruple therapy

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

Group Type ACTIVE_COMPARATOR

Bismuth potassium citrate containing quadruple therapy

Intervention Type DRUG

Bismuth potassium citrate:given for 14 days at a dose of bismuth potassium citrate 220 mg 0 BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID

Colloidal pectin bismuth capsules containing quadruple therapy

Intervention Type DRUG

Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth capsules 200 mg 0 BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID

Colloidal pectin bismuth particles A quadruple therapy

Intervention Type DRUG

Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth particles 150 mg BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID

Colloidal pectin bismuth particles B quadruple therapy

Intervention Type DRUG

Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth particles 300 mg BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID

Colloidal pectin bismuth particles B quadruple therapy

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

Group Type ACTIVE_COMPARATOR

Bismuth potassium citrate containing quadruple therapy

Intervention Type DRUG

Bismuth potassium citrate:given for 14 days at a dose of bismuth potassium citrate 220 mg 0 BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID

Colloidal pectin bismuth capsules containing quadruple therapy

Intervention Type DRUG

Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth capsules 200 mg 0 BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID

Colloidal pectin bismuth particles A quadruple therapy

Intervention Type DRUG

Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth particles 150 mg BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID

Colloidal pectin bismuth particles B quadruple therapy

Intervention Type DRUG

Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth particles 300 mg BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID

Interventions

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Bismuth potassium citrate containing quadruple therapy

Bismuth potassium citrate:given for 14 days at a dose of bismuth potassium citrate 220 mg 0 BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID

Intervention Type DRUG

Colloidal pectin bismuth capsules containing quadruple therapy

Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth capsules 200 mg 0 BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID

Intervention Type DRUG

Colloidal pectin bismuth particles A quadruple therapy

Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth particles 150 mg BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID

Intervention Type DRUG

Colloidal pectin bismuth particles B quadruple therapy

Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth particles 300 mg BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No