Comparing Different Regimens for Eradication of Helicobacter Pylori in Kuwait

NCT ID: NCT04617613

Last Updated: 2020-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 603 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2019-12-31

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.

Conditions

Helicobacter Pylori Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Standard triple therapy

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

Group Type: ACTIVE_COMPARATOR

Omeprazole, Amoxicillin and Clarithromycin

Intervention Type: 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.

Quadruple therapy group

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

Group Type: EXPERIMENTAL

Omeprazole, Amoxicillin, Metronidazole and Clarithromycin

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Omeprazole, Amoxicillin 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.

Intervention Type: DRUG

Other Intervention Names

Quadruple therapy group; Standard triple therapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Kuwait

OTHER_GOV

Sponsor Role: collaborator

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Alboraie

Postgraduate clinical researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Alfadhli A, Alboraie M, Afifi M, Dangi A. A Randomized Clinical Trial Comparing Triple Therapy versus Non-bismuth based Quadruple Therapy for the Eradication of Helicobacter Pylori in Kuwait. J Glob Infect Dis. 2022 Aug 26;14(3):99-105. doi: 10.4103/jgid.jgid_13_22. eCollection 2022 Jul-Sep.

Reference Type: DERIVED

PMID: 36237565 (View on PubMed)

Other Identifiers

MKH-01-2016

Identifier Type: -

Identifier Source: org_study_id