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Completed

NCT Number: NCT04617613

Comparing Different Regimens for Eradication of Helicobacter Pylori in Kuwait

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omeprazole, Amoxicillin, Metronidazole and Clarithromycin

Drug

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.

Other names: Quadruple therapy group

Omeprazole, Amoxicillin and Clarithromycin

Drug

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.

Other names: Standard triple therapy

Primary outcomes

  1. Negative 13-Carbon urea breath test

    Time frame: One month

    H. pylori eradication rate defined as negative 13-Carbon urea breath test (13C-UBT) one month after treatment

  2. Adverse events

    Time frame: One month

    Any reported adverse events during the study period

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Collaborators

  • Ministry of Health, Kuwait

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Nov 5, 2020
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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