Quadruple Therapy Versus Dual Therapy as Rescue Regimens for Helicobacter Pylori Infection

Study Overview
=================
Brief Summary
-----------------
The eradication rates of first-line treatment for Helicobacter pylori(Hp) infection are not satisfactory. The study aims to compare the efficacy and safety between quadruple therapy with furazolidone and dual therapy with high doses of amoxicillin as rescue regimens for Hp.

Official Title
-----------------
Quadruple Therapy With Furazolidone Versus Dual Therapy With High Doses of Amoxicillin as Rescue Regimens for Helicobacter Pylori Infection

Conditions
-----------------
Rescue Therapy for Helicobacter Pylori

Intervention / Treatment
-----------------
* Drug: RBLF
* Drug: RA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged from 18 to 80 years, who presented with upper gastrointestinal symptoms and endoscopically proven H. pylori-positive non-ulcer dyspepsia, were recruited into the study. Exclusion Criteria: patients with peptic ulcer, previous H. pylori eradication treatment, previous gastric surgery, pregnancy, lactation, major systemic diseases, receipt of anti-secretory therapy, antibiotics or bismuth in the preceding four weeks, or - allergy to any one of the medications in the regimen.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group RBLF<br>receive a 14-day quadruple therapy,including rabeprazole(10mg bid),bismuth citrate(220mg bid),levofloxacin(200mg qm) and furazolidone(100mg bid). | Drug: RBLF<br>* The patients in Group RBLF will receive a 14-day quadruple therapy,including rabeprazole(10mg bid),bismuth citrate(220mg bid),levofloxacin(200mg qm) and furazolidone(100mg bid).<br>|
| Active Comparator: Group RA<br>receive a 14-day dual therapy with high doses of rabeprazole(20mg bid) and amoxicillin(1000mg tid). | Drug: RA<br>* The patients in Group RA will be sent to a penicillin skin test before treatment except they were given penicillin before. They will receive a 14-day dual therapy with high doses of rabeprazole(20mg bid) and amoxicillin(1000mg tid).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 13C-urea breath test | When the outcome of 13C-urea breath test is more than 4%, the helicobacter pylori infection is still exist(positive). | 4 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| scale analysis of drug safety |  | 4 weeks after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Helicobacter pylori, rescue, quadruple therapy，dual therapy