A Unique Regimen for Treatment of Helicobacter Pylori Infection

Study Overview
=================
Brief Summary
-----------------
The triple treatment including Proton pump inhibitor (PPI) -clarithromycin and amoxicillin or metronidazole was proposed 30 years ago at the first Maastricht conference to treat helicobacter pylori (H. pylori) infection and since that time, it has become the universal and standard treatment for helicobacter pylori. However, the efficacy of this triple regimen has been seriously challenged, and they are gradually becoming ineffective

Detailed Description
-----------------
Growing rates of treatment failure are observed worldwide and the eradication rate of triple therapy has declined over the past few decades. Helicobacter pylori infection has become increasingly resistant to traditional first line treatment regimens because of emerging antibiotic resistance coupled with poor patient compliance with completing the treatment course that decrease H. pylori eradication rates .So there is a considerable interest in evaluating new antibiotic combinations and regimens .

Official Title
-----------------
A Unique Quadruple Regimen for of Helicobacter Pylori

Conditions
-----------------
Helicobacter Infections

Intervention / Treatment
-----------------
* Drug: Quadruple therapy
* Drug: Classic treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged older than 21 years Presenting by Dyspepsia Infected by H. pylori (as proved by positive stool antigen test) Agreed to participate in the study and signed the consent Exclusion Criteria: Patients who have received treatment with proton pump inhibitors within 2 weeks, NSAID or antibiotics within 4 weeks before study entry Patients who had received H pylori treatment before. Patients presenting by upper gastrointestinal bleeding Pregnant females Patients who have significant gastrointestinal, renal, hepatic, cardiovascular, metabolic, hematological disease.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quadruple therapy<br>Moxifloxacin, Nitazoxanide, Omeprazole sodium bicarbonate, Doxycyclin | Drug: Quadruple therapy<br>* Moxifloxacin, omeprazole sodium bicarbonate, nitazoxanide, doxycyclin<br>* Other names: Moxiflox, Downoprazol, Nanazoxid, Doxymycin;|
| Active Comparator: Classic treatment<br>Omeprazole, clarithromycin, amoxicillin | Drug: Classic treatment<br>* Omeprazole, amoxycillin, clarithromycin<br>* Other names: Downoprazol, Emox, Klacid;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with eradicated Helicobacter infection | Number of patients with eradicated infection | 6 months |