Comparing Different Regimens for Eradication of Helicobacter Pylori in Kuwait

Study Overview
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Brief Summary
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Eradication of H. pylori reduces morbidity in patients with chronic gastritis and can prevent gastric cancer. We aimed to evaluate the efficacy of clarithromycin-based triple therapy and non-bismuth based quadruple therapy for eradicating H. pylori in patients with chronic gastritis in Kuwait.

Detailed Description
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Helicobacter pylori (H. pylori) induced chronic infection is associated with peptic ulcer, chronic gastritis, gastric cancer, and increasing antibiotic resistance. Eradication of H. pylori reduces morbidity in patients with chronic gastritis and can prevent gastric cancer in the high-risk population. We aimed to evaluate the efficacy of clarithromycin-based triple therapy and non-bismuth based quadruple therapy for eradicating H. pylori in patients with chronic gastritis in Kuwait. We enrolled treatment-naive dyspeptic patients with gastric biopsy-proven chronic gastritis secondary to H. pylori in a prospective, open-label, randomized study conducted at the gastroenterology outpatient clinics of Haya Habeeb gastroenterology center in Kuwait. Patients were randomized into two groups: the first group received the standard triple therapy (omeprazole, amoxicillin, and clarithromycin) for 14 days; and the second group received quadruple therapy (omeprazole, amoxicillin, clarithromycin, and metronidazole) for 14 days. All patients were tested for the eradication of H. pylori by carbon-13 urea breath test (13C-UBT) one month after completion of eradication therapy.

Official Title
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Comparing Different Regimens for Eradication of Helicobacter Pylori in Kuwait

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Omeprazole, Amoxicillin, Metronidazole and Clarithromycin
* Drug: Omeprazole, Amoxicillin and Clarithromycin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female dyspeptic subjects aged ≥18 years with any nationality Patients with gastric biopsy-proven H. pylori related chronic gastritis and no other abnormalities in the upper gastrointestinal tract upon endoscopy Patients who were naive to treatment for H. pylori infection. Exclusion Criteria: Pregnant or breastfeeding females Patients who were previously treated for H. pylori infection Patients who received any antibiotics, bismuth or acid-suppressant drugs within the last month

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard triple therapy<br>Standard triple therapy group received omeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg twice daily for 14 days. | Drug: Omeprazole, Amoxicillin and Clarithromycin<br>* The first group (standard triple therapy group) received omeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg. The second group (quadruple therapy group) received omeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg. Patients in both groups received omeprazole capsule twice daily before meals and the rest of the drugs twice daily after meals for 14 days.<br>* Other names: Standard triple therapy;|
| Experimental: Quadruple therapy group<br>Quadruple therapy group received omeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg twice daily after meals for 14 days. | Drug: Omeprazole, Amoxicillin, Metronidazole and Clarithromycin<br>* The first group (standard triple therapy group) received omeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg. The second group (quadruple therapy group) received omeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg. Patients in both groups received omeprazole capsule twice daily before meals and the rest of the drugs twice daily after meals for 14 days.<br>* Other names: Quadruple therapy group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative 13-Carbon urea breath test | H. pylori eradication rate defined as negative 13-Carbon urea breath test (13C-UBT) one month after treatment | One month | 
| Adverse events | Any reported adverse events during the study period | One month |