Comparing Different Regimens for Eradication of Helicobacter Pylori in Kuwait

Helicobacter Pylori Infection Clinical Trial

Official title:

Comparing Different Regimens for Eradication of Helicobacter Pylori in Kuwait

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04617613
• Other study ID #: MKH-01-2016
• Status: Completed
• Phase: Phase 4
• Start date: September 2016
• Est. completion date: December 2019

Study information

• Verified date: October 2020
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 603
• Est. completion date: December 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Al-Azhar University	Ministry of Health, Kuwait

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative 13-Carbon urea breath test	H. pylori eradication rate defined as negative 13-Carbon urea breath test (13C-UBT) one month after treatment	One month
Primary	Adverse events	Any reported adverse events during the study period	One month