A Comparative Study Between Concomitant Versus Load Therapy in Eradication of Helicobacter Pylori Infection

Study Overview
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Brief Summary
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All patients who presented with epigastric pain and dyspeptic symptoms will undergo endoscopic gastric biopsies. The patients will be subjected to: Full history taking, clinical examination, liver function tests, renal function tests, CBC, INR, abdominal ultrasonography. About 200 patients diagnosed to have H. pylori by infection by microscopically examined, endoscopic gastric biopsies will be enrolled in our study. All available formalin fixed and paraffin embedded tissue blocks of gastric endoscopic biopsies will be resectioned and stained with Haematoxylin and Eosin. Modified Giemsa stain, and Alcian blue/ PAS stain will be used for verification of Helicobacter pylori and demonstration of intestinal metaplasia respectively. Biopsies will be classified using the Updated Sydney system of classification of gastritis

Detailed Description
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The patients will be randomized (closed envelopes) into one of two groups: patients will receive concomitant therapy comprising of pantoprazole (40 mg twice daily), amoxicillin (1 gm twice a day), clarithromycin (500 mg twice a day) and metronidazole (500 mg twice a day) for 2 weeks. patients will receive LOAD therapy comprising of levofloxacin (250 mg with breakfast), omeprazole (40 mg before breakfast), nitazoxanide (Alina) (500 mg twice daily with meals) and doxycycline (100 mg at dinner) for 10 days. H. Pylori eradication will be confirmed by H. Pylori stool antigen testing at least 4 weeks after cessation of antibiotic therapy with stoppage of PPI therapy at least one to two weeks.

Official Title
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A Comparative Study Between Concomitant Versus Load Therapy in Eradication of Helicobacter Pylori Infection

Conditions
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H. Pylori Infection

Intervention / Treatment
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* Drug: Comparing Load and Concomitant therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients who presented with epigastric pain and dyspeptic symptoms Exclusion Criteria: Patients recently (within 6 months) treated with anti-H. pylori therapy. Allergy to any drugs used in our protocol Patients on PPI, antibiotics, and steroid or non-steroidal anti-inflammatory drugs within past one month before randomization. Concomitant significant comorbidities (advanced cardiac, renal, hepatic disease). Presence of GI malignancy. Pregnancy or lactating women. Unable or refuse to give consent. -
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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: concomitant<br>Clarithro -pantoprazole- Metronidazole - Amoxicyllin | Drug: Comparing Load and Concomitant therapy<br>* Levofloxacin - Omeprazole - nitazoxanide - doxycycline<br>* Other names: Clarithromycin - pantoprazole - Metronidazole - Amoxycyllin;|
| Active Comparator: LOAD<br>Levofloxacin -omeprazole- nitazoxanide- Doxycycline | Drug: Comparing Load and Concomitant therapy<br>* Levofloxacin - Omeprazole - nitazoxanide - doxycycline<br>* Other names: Clarithromycin - pantoprazole - Metronidazole - Amoxycyllin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication of H. pylori infection after treatment | Negative stool antigen test for H.pylori | 4 weeks after end of treatment |