Quadruple Therapy for Triple Therapy Resistant Helicobacter Pylori Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-06-30

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.

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Detailed Description

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Conditions

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Treatment of Helicobacter Pylori

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Quadruple Therapy

Group Type EXPERIMENTAL

Augmentin (Amoxicillin-clavulanic)

Intervention Type DRUG

Amoxicillin-clavulanic acid 1 gram b.i.d

Furoxone (furazolidone)

Intervention Type DRUG

furazolidone 200 mg b.i.d

Cebes (colloidal bismuth subcitrate)

Intervention Type DRUG

colloidal bismuth subcitrate 240 mg b.i.d

Esso (esomeprazole)

Intervention Type DRUG

esomeprazole 40 mg b.i.d for 14 days

Interventions

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Augmentin (Amoxicillin-clavulanic)

Amoxicillin-clavulanic acid 1 gram b.i.d

Intervention Type DRUG

Furoxone (furazolidone)

furazolidone 200 mg b.i.d

Intervention Type DRUG

Cebes (colloidal bismuth subcitrate)

colloidal bismuth subcitrate 240 mg b.i.d

Intervention Type DRUG

Esso (esomeprazole)

esomeprazole 40 mg b.i.d for 14 days

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No