A Phase 4 interventional study of Omeprazole, Amoxicillin, Metronidazole and Clarithromycin and Omeprazole, Amoxicillin and Clarithromycin in Helicobacter Pylori Infection, sponsored by Al-Azhar University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-05.
Sponsored by Al-Azhar University · Phase 4, Interventional, and Treatment
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.
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.
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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
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
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.
Also known as: Quadruple therapy group
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.
Also known as: Standard triple therapy
Negative 13-Carbon urea breath test
H. pylori eradication rate defined as negative 13-Carbon urea breath test (13C-UBT) one month after treatment
Time frame: One month
Adverse events
Any reported adverse events during the study period
Time frame: One month
No study locations are listed for this record.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Al-Azhar University