Quadruple Therapy for Triple Therapy Resistant Helicobacter Pylori Infection

Study Overview
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Brief Summary
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Triple therapy, a combination of proton pump inhibitor with two antibiotics, is the gold standard for anti-Helicobacter pylori treatment. Usual antibiotics are clarithromycin, and either amoxicillin or one of the nitroimidazoles (metronidazole). However, there is an increasing evidence of H. pylori resistance to classical triple therapy. Another reason for this failure being low patient compliance with treatment. A regimen useful in one geographical area may not be effective or practical in another area. The aim of this study was to eradicate H. pylori infection resistant to triple therapy, establish the efficacy and safety of a 14-day therapeutic regimen to eradicate of H. pylori in patients who have failed with the classical triple therapy (omeprazole, clarithromycin and amoxicillin) given for 14 days.

Official Title
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Quadruple Therapy Using Esomeprazole, Colloidal Bismuth Subcitrate, Amoxicillin-Clavulanate, and Furazolidone in Patients Who Failed to Eradicate H. Pylori With Triple Therapy

Conditions
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Treatment of Helicobacter Pylori

Intervention / Treatment
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* Drug: Augmentin (Amoxicillin-clavulanic)
* Drug: Furoxone (furazolidone)
* Drug: Cebes (colloidal bismuth subcitrate)
* Drug: Esso (esomeprazole)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent given by the patient Patients known to have H. pylori infection diagnosed by histopathology, rapid urease test and urea breath test Failure to respond to classical triple regime of amoxicillin 1gram, clarithromycin 500mg and omeprazole 20mg twice a day for 10-14 days as documented by repeat urea breath test done one month after eradication therapy Exclusion Criteria: Evidence of any malignancy, gastric outlet syndrome, history of gastric surgery, chronic liver disease, severe chronic renal failure, or any major co-morbidity. known or suspected hypersensitivity to the medication used in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quadruple Therapy<br> | Drug: Augmentin (Amoxicillin-clavulanic)<br>* Amoxicillin-clavulanic acid 1 gram b.i.d<br>Drug: Furoxone (furazolidone)<br>* furazolidone 200 mg b.i.d<br>Drug: Cebes (colloidal bismuth subcitrate)<br>* colloidal bismuth subcitrate 240 mg b.i.d<br>Drug: Esso (esomeprazole)<br>* esomeprazole 40 mg b.i.d for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication of H. pylori infection resistant to triple therapy. |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the quadruple therapy |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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H.pylori, Triple therapy failure, Quadruple therapy