A Two Week Nitazoxanidebased Quadruple Regimen

Study Overview
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Brief Summary
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Helicobacter pylori (H. pylori) infection is a global health problem as it is associated with peptic ulcers, chronic gastritis, duodenitis, and stomach cancer. Therefore, the eradication of the pathogen is of critical importance to reduce H. pylori-related complications . However, due to increasing antibiotic resistance, eradication of Helicobacter pylori has become more challenging. With a great decline in the eradication rate of standard triple therapy for Helicobacter pylori to below 70% in many countries. Treatment with triple therapy, which is the most frequently recommended, fails to eradicate H. pylori in approximately 20% of cases .

Detailed Description
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Designing a new rescue regimen that achieves greater than 85% eradication rate is an important target of current research. Unfortunately, the most frequently used rescue or salvage therapy is bismuth quadruple therapy consisting of a proton pump inhibitor (PPI), tetracycline, metronidazole, and bismuth [11]. This rescue therapy is inexpensive, and relatively effective with average eradication rate of 70% when used as second-line therapy. However, disadvantages of bismuth based quadruple therapy include the large daily number of pills (sometimes exceeding 18 pills), increased dosing frequency (four times daily), and frequent side effects.

Official Title
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A Two Week Nitazoxanidebased Quadruple Regimen for Helicobacter Pylori Therapy After Failure of Standard Triple Therapy: A Single Center Experience

Conditions
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Dyspepsia

Intervention / Treatment
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* Drug: Nitazoxanide
* Drug: Levofloxacin
* Drug: Doxycyclin
* Drug: Omeprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with helicobacter infection. in whom the standard triple therapy (clarithromycin-based triple therapy) failed Exclusion Criteria: Patients under 18 or over 65 years of age. Those with co-existing serious illnesses such as liver cirrhosis, uremia and gastrointestinal malignancies pregnancy/lactation having contraindication or allergy to any of the study drugs
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quadruple therapy<br>Nitazoxanide (500mg bid), Levofloxacin (500 mg once daily), Omeprazole (40 mg bid) and doxycyclin (100 mg twice daily) were prescribed for 14 days. | Drug: Nitazoxanide<br>* Nitazoxanide 500 mg twice daily<br>* Other names: Alenia, nitclean, parazoxanide;Drug: Levofloxacin<br>* Levofloxacin 500 mg once daily<br>* Other names: Tavanic, levoxin, venaxan.;Drug: Doxycyclin<br>* Doxycyclin 100 mg twice daily<br>* Other names: Vibramycin, Doxymycin;Drug: Omeprazole<br>* Omeprazole 40 mg twice daily<br>* Other names: Omepak, Pepzole, Gasec, Risek.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with eradicated helicobacter | The total number of patients with eradicated helicobacter | 1 year |