Comparing Different Regimens for Eradication of Helicobacter Pylori in Kuwait

Phase 4

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Omeprazole, Amoxicillin and Clarithromycin; Drug: Omeprazole, Amoxicillin, Metronidazole and Clarithromycin

• Registration Number: NCT04617613
• Lead Sponsor: Al-Azhar University

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-09
• Primary Completion: 2018-09
• Study Completion: 2019-12
• Status Verified: 2020-10
• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-10-30
• Last Update Submitted: 2020-10-30
• Study First Posted: 2020-11-05
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 603

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard triple therapy	Omeprazole, Amoxicillin and Clarithromycin	Standard triple therapy group received omeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg twice daily for 14 days.
Quadruple therapy group	Omeprazole, Amoxicillin, Metronidazole 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.

Primary Outcome Measures

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