A Comparison of Clarithromycin-based and Furazolidone-based Bismuth-containing Regimens for H. Pylori Eradication

Study Overview
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Brief Summary
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We aim to assess and compare the effectiveness of clarithromycin- and furazolidone-based regimens as primary therapies in eradicating H. pylori.

Detailed Description
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Helicobacter pylori plays a pivotal role in many diseases such as peptic ulcer disease and MALT lymphomas. And the prevalence of H. pylori is increasing in some parts of the world. However, the eradication becomes increasingly difficult due to the growing antibiotic resistance. Bismuth-containing quadruple regimens are now recommended to serve as first-line therapies. Bismuth-clarithromycin-containing and bismuth-furazolidone-containing quadruple regimens are both in the list of the first regimens. And recent antimicrobial susceptibility tests showed us that the clarithromycin was increasingly resisted while furazolidone remained hardly resisted. The comparison between the effects of bismuth-clarithromycin-containing and bismuth-furazolidone-containing quadruple regimens is not so clear.

Official Title
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A Comparison of Clarithromycin-based and Furazolidone-based Bismuth-containing Regimens for H. Pylori Eradication

Conditions
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Helicobacter Pylori

Intervention / Treatment
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* Drug: Furazolidone
* Drug: Clarithromycin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients, aged between 18 and 75years old, with positive H. pylori infection that was not eradicated by previous therapies are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test. Exclusion Criteria: Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bismuth-clarithromycin-containing group<br>Patients in bismuth-clarithromycin-containing group will receive lansoprazole (Takepron) 30mg po bid, amoxicillin 1000mg po bid, bismuth subcitrate (Colloidal Bismuth Pectin) 200mg po bid, and clarithromycin (Klacid) 500mg po bid for 14d | Drug: Clarithromycin<br>* bismuth-clarithromycin-containing quadruple regimens<br>|
| Experimental: bismuth-furazolidone-containing quadruple group<br>patients in bismuth-furazolidone-containing quadruple group will receive lansoprazole (Takepron) 30mg po bid, amoxicillin 1000mg po bid, bismuth subcitrate (Colloidal Bismuth Pectin) 240mg po bid, and furazolidone (Liteling) 100mg po bid for 14d | Drug: Furazolidone<br>* bismuth-furazolidone-containing quadruple regimens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the eradication rate of the two groups |  | 26 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter Pylori, furazolidone, clarithromycin, bismuth-containing quadruple regimen