Comparing Different Regimens for Eradication of Helicobacter Pylori in Kuwait

Al-Azhar University

Status and phase: Completed; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Omeprazole, Amoxicillin, Metronidazole and Clarithromycin; Drug: Omeprazole, Amoxicillin and Clarithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT04617613

MKH-01-2016

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 603 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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603 participants in 2 patient groups

Standard triple therapy

Active Comparator group

Description:

Standard triple therapy group received omeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg twice daily for 14 days.

Treatment:

Drug: Omeprazole, Amoxicillin and Clarithromycin

Quadruple therapy group

Experimental group

Description:

Quadruple therapy group received omeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg twice daily after meals for 14 days.

Treatment:

Drug: Omeprazole, Amoxicillin, Metronidazole and Clarithromycin