Helicobacter Pylori Eradication With Berberine Hydrochloride, Lansoprazole, Amoxicillin and Bismuth Versus Clarithromycin Bismuth, Lansoprazole and Amoxicillin: A Randomized, Open-label, Non-inferiority, Phase Ⅳ Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 566
- Locations
- 2
- Primary Endpoint
- helicobacter pylori eradication
Study Overview
Brief Summary
This study aims at evaluating efficacy and safety of berberine-containing quadruple therapy(berberine, lansoprazole, bismuth and amoxicillin) versus clarithromycin-containing quadruple therapy (clarithromycin,lansoprazole, bismuth and amoxicillin) in H. pylori eradication. It is hypothesized that berberine-containing quadruple therapy is non-inferior to clarithromycin-containing quadruple therapy. Patients with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 2 and 6 follow-up visits, a urea breath test(UBT) will be performed to confirm eradication.
Detailed 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age between 18~70,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)
- •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.
- •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).
- •Enrolled in other clinical trials in the past 3 months.
Arms & Interventions
berberine quadruple therapy
Berberine 300 mg, three times daily for 14 days,lansoprazole 30 mg,amoxicillin 1000 mg, and Bismuth 220 mg by mouth, twice daily for 14 days.
Intervention: Berberine (Drug)
berberine quadruple therapy
Berberine 300 mg, three times daily for 14 days,lansoprazole 30 mg,amoxicillin 1000 mg, and Bismuth 220 mg by mouth, twice daily for 14 days.
Intervention: Bismuth (Drug)
berberine quadruple therapy
Berberine 300 mg, three times daily for 14 days,lansoprazole 30 mg,amoxicillin 1000 mg, and Bismuth 220 mg by mouth, twice daily for 14 days.
Intervention: Lansoprazole (Drug)
berberine quadruple therapy
Berberine 300 mg, three times daily for 14 days,lansoprazole 30 mg,amoxicillin 1000 mg, and Bismuth 220 mg by mouth, twice daily for 14 days.
Intervention: amoxicillin (Drug)
clarithromycin quadruple therapy
Bismuth 220 mg, lansoprazole30 mg, amoxicillin 1000 mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
Intervention: clarithromycin (Drug)
clarithromycin quadruple therapy
Bismuth 220 mg, lansoprazole30 mg, amoxicillin 1000 mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
Intervention: Bismuth (Drug)
clarithromycin quadruple therapy
Bismuth 220 mg, lansoprazole30 mg, amoxicillin 1000 mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
Intervention: Lansoprazole (Drug)
clarithromycin quadruple therapy
Bismuth 220 mg, lansoprazole30 mg, amoxicillin 1000 mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
Intervention: amoxicillin (Drug)
Outcomes
Primary Outcomes
helicobacter pylori eradication
Time Frame: 28 days after treatment
The primary end point of this study is H.pylori eradication,established by negative \[13C\] urea breath test 28 days after the end of eradication.
Secondary Outcomes
- symptoms effective rates(14 days of treatment, and 28 days after treatment)
- adverse events(14 days of treatment, and 28 days after treatment)
Investigators
Yongquan Shi
Doctor of Xijing Hospital of Digestive Diseases,Principal investagator,Clinical professor
Xijing Hospital of Digestive Diseases