Helicobacter Rescue Therapy With Berberine Plus Amoxicillin Quadruple Therapy Versus Tetracycline Plus Furazolidone Quadruple Therapy
Study Details
Study Description
Brief Summary
This study aims at evaluating efficacy and safety of berberine- amoxicillin containing quadruple therapy(berberine, amoxicillin, esomeprazole and bismuth) versus tetracycline-furazolidone quadruple therapy (tetracycline, furazolidone, esomeprazole and bismuth) in H. pylori rescue therapy. It is hypothesized that berberine-amoxicillin containing quadruple therapy is non-inferior to tetracycline-furazolidone quadruple therapy. Patients with confirmed failure of H. pylori eradication will be randomized to one of the treatments described above. At week 6 follow-up visits, a urea breath test,rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Detailed Description
Detailed Description:
The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent. One of urea breath test,rapid urease test or helicobacter pylori stool antigen 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 13 and 17.
Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication of H. Pylori will be confirmed by one of urea breath test,rapid urease test or helicobacter pylori stool antigen test。
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: berberine plus amoxicillin quadruple therapy Berberine 500mg three time daily for 14days, amoxicillin 1000 mg, esomeprazole 20 mg, and Bismuth 200mg by mouth, twice daily for 14 days. |
Drug: Berberine
Berberine-amoxicillin quadruple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ,esomeprazole 20 mg BID, ,and Bismuth 100 mg 2 capsules BID.
Drug: Amoxicillin
Berberine-amoxicillin quadruple therapy group: given for 14 days at a dose of Amoxicillin 500 mg 2 capsules BID plus berberine 100 mg 3 tablets TID, esomeprazole 20mg 1tablet BID, and bismuth 100 mg 2 capsules BID
Other Names:
Drug: Esomeprazole
Berberine-amoxicillin quadruple therapy group: given for 14 days at a dose of Esomeprazole 20mg 1 tablet BID plus berberine 100 mg 3 tablets TID,amoxicillin 500 mg 2 capsules BID, and bismuth 100 mg 2 capsules BID
Other Names:
Drug: Bismuth
Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of Tetracycline 250mg 2 capsules TID plus furazolidone 100mg 1 tablets BID,esomeprazole 20 mg 1 tablets BID and bismuth 100 mg 2 capsules BID
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Active Comparator: tetracycline plus furazolidone quadruple therapy Tetracycline 500mg three time daily for 14days,furazolidone 100 mg, esomeprazole 20 mg, and Bismuth 200mg by mouth, twice daily for 14 days. |
Drug: Tetracycline
Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of Tetracycline 250mg 2 capsulesTID plus furazolidone 100mg 1 tablets BID,esomeprazole 20 mg 1 tablets BID and bismuth 100 mg 2 capsules BID
Drug: Furazolidone
Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of furazolidone 100mg 1 tablets BID plus Tetracycline 250mg 2 capsulesTID,esomeprazole 20 mg 1 tablets BID and bismuth 100 mg 2 capsules BID
Drug: Esomeprazole
Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of esomeprazole 20 mg 1 tablets BID plus Tetracycline 250mg 2 capsules TID, furazolidone 100mg 1 tablets BID, and bismuth 100 mg 2 capsules BID
Other Names:
Drug: Bismuth
Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of bismuth 100 mg 2 capsules BID plus Tetracycline 250mg 2 capsules TID ,furazolidone 100mg 1 tablets BID and esomeprazole 20 mg 1 tablets BID
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Outcome Measures
Primary Outcome Measures
- Helicobacter pylori eradication [28 days after treatment]
The primary end point of this study is H.pylori eradication,established by negative urea breath test,rapid urease test or helicobacter pylori stool antigen test 28 days after the end of treatment.
Secondary Outcome Measures
- symptoms effective rates [14 days of treatment, and 28 days after treatment]
Evaluation effective rate of symptoms 2 weeks of treatment and 4 weeks after the end of treatment. Symptom effective rate =(total score before treatment - total score after treatment)/total score before treatment x 100%. Total score = frequency * severity. Frequency score is calculated by all the frequency of heartburn, reflux, abdominal pain, and flatulence. Severity is accumulated by the degree of symptoms described above, which is divided to 4 degree as 0 presenting none, and 3 presenting most severe
- adverse events [14 days of treatment, and 28 days after treatment]
Participants with Adverse Events as a Measure of Safety and Tolerability.The common side effects of the study include headache, dizziness, skin rash, other gastrointestinal disorders, pyrexia, cough and back pain.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients who had failed H.pylori eradication therapies before.
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Age between 18~70, both gender.
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Patients who had failed H.pylori eradication therapies during last 2 years and stop the eradication therapies for at least 2 months.
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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:
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Patients are excluded if they have previously used tetracycline and furazolidone antibiotics to eradicate infection with H. pylori.
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Contraindications to study drugs.
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Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease.
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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).
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Pregnant or lactating women.
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Underwent upper gastrointestinal Surgery.
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Patients with Barrett esophageal or highly atypical hyperplasia, have symptom of dysphagia.
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Evidence of bleeding or iron efficiency anemia.
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A history of malignancy.
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Drug or alcohol abuse history in the past 1 year.
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Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
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Enrolled in other clinical trials in the past 3 months.
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Patients who has psychological problem or poor compliance.
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Refuse to sign informed consent.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Xijing Hosipital of Digestive Disease | Xi'an | Shaanxi | China | 710032 |
Sponsors and Collaborators
- Xijing Hospital of Digestive Diseases
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KY20182043-1