Comparative Effectiveness of Triple Versus Quadruple Therapy in the Treatment of Helicobacter Pylori Induced Gastritis

NCT ID: NCT07312721

Last Updated: 2025-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 752 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-05
• Study Completion Date: 2024-12-30

Brief Summary

This randomized controlled trial is designed to compare the efficacy of standard triple therapy versus bismuth-based quadruple therapy for the eradication of Helicobacter pylori-induced gastritis. The study is being conducted at Shahida Islam Medical College, Lodhran, Pakistan. Adult patients with confirmed H. pylori infection are randomly allocated to receive either a 14-day triple therapy regimen or a 14-day bismuth-based quadruple therapy regimen. Eradication of H. pylori is assessed six weeks after completion of treatment using stool antigen testing. The primary outcome measure is the proportion of patients achieving successful eradication of H. pylori.

Detailed Description

Background:

Helicobacter pylori infection is a major cause of chronic gastritis, peptic ulcer disease, and gastric malignancy. Standard triple therapy has historically been used as first-line treatment; however, increasing antibiotic resistance has led to declining eradication rates in many regions. Bismuth-based quadruple therapy has emerged as an alternative regimen and is recommended in areas with suspected or confirmed antibiotic resistance.

Objective:

To compare the efficacy of standard triple therapy versus bismuth-based quadruple therapy in achieving eradication of Helicobacter pylori in adult patients with H. pylori-induced gastritis.

Study Design and Methods:

This is a randomized controlled trial conducted in the Department of Medicine at Shahida Islam Medical College, Lodhran, Pakistan. Adult patients aged 18 to 65 years with confirmed H. pylori infection based on stool antigen testing are eligible for inclusion. Participants are randomly assigned in a 1:1 ratio to one of two treatment groups. One group receives standard triple therapy consisting of omeprazole, amoxicillin, and clarithromycin for 14 days. The second group receives bismuth-based quadruple therapy consisting of omeprazole, metronidazole, tetracycline, and bismuth subsalicylate for 14 days.

Patients are followed for six weeks after completion of therapy. Eradication of H. pylori is evaluated using repeat stool antigen testing. The primary outcome measure is successful eradication of H. pylori. Secondary analyses include assessment of eradication outcomes across demographic and clinical subgroups.

Ethical Approval:

The study protocol has been approved by the Institutional Review Board of Shahida Islam Medical College (IRB No. SIMC/ETC/0008/24, dated 05 January 2024). Written informed consent is obtained from all participants prior to enrollment.

Conditions

Helicobacter Pylori Infection; Chronic Gastritis; Peptic Ulcer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Triple Therapy Group

Participants received Omeprazole 40 mg twice daily, Amoxicillin 1 g twice daily, and Clarithromycin 500 mg twice daily for 14 days.

Group Type: EXPERIMENTAL

Triple Therapy

Intervention Type: DRUG

Omeprazole 40 mg BID, Amoxicillin 1 g BID, Clarithromycin 500 mg BID for 14 days.

Quadruple Therapy Group

Participants received Omeprazole 40 mg twice daily, Metronidazole 400 mg three times daily, Tetracycline 500 mg every six hours, and Bismuth subsalicylate for 14 days.

Group Type: EXPERIMENTAL

Quadruple Therapy

Intervention Type: DRUG

Omeprazole 40 mg BID, Metronidazole 400 mg TID, Tetracycline 500 mg QID, Bismuth subsalicylate for 14 days.

Interventions

Triple Therapy

Omeprazole 40 mg BID, Amoxicillin 1 g BID, Clarithromycin 500 mg BID for 14 days.

Intervention Type: DRUG

Quadruple Therapy

Omeprazole 40 mg BID, Metronidazole 400 mg TID, Tetracycline 500 mg QID, Bismuth subsalicylate for 14 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adults aged 18-65 years.

Confirmed Helicobacter pylori infection based on a positive stool antigen test.

Willing and able to provide written informed consent.

Exclusion Criteria

History of allergy or hypersensitivity to any of the study drugs (omeprazole, amoxicillin, clarithromycin, metronidazole, tetracycline, or bismuth compounds).

Prior H. pylori eradication therapy.

Pregnancy or lactation.

History of gastrointestinal bleeding, peptic ulcer perforation, or prior gastric surgery.

Chronic renal failure or hepatic dysfunction.

Current use of proton pump inhibitors or antibiotics within the previous six weeks.

Use of traditional (Hakeem) medications or herbal remedies affecting gastric function.

Psychiatric illness or inability to comply with treatment and follow-up.

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azfar Farogh

OTHER

Sponsor Role: lead

Responsible Party

Azfar Farogh

Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Prof. Dr. Azfar Farogh

Role: PRINCIPAL_INVESTIGATOR

Shahida Islam Medical College, Lodhran

Locations

Shahida Islam Medical College, Lodhran

Lodhran, Punjab Province, Pakistan

Countries

Pakistan

References

Miao R, Chen J, Gao S, Wang L, Zhou W, Wan C, Wang Z. A randomised controlled clinical study of standard triple therapy, bismuth-based quadruple therapy and sequential therapy for Helicobacter pylori infection in children. BMC Pediatr. 2024 Aug 23;24(1):543. doi: 10.1186/s12887-024-05020-6.

Reference Type: RESULT

PMID: 39180014 (View on PubMed)

Other Identifiers

SIMC/ETC/0008/24

Identifier Type: -

Identifier Source: org_study_id