A Phase 4 interventional study of Triple Therapy and Quadruple Therapy in Helicobacter Pylori Infection, Chronic Gastritis and Peptic Ulcer Disease, sponsored by Azfar Farogh. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-31.
Sponsored by Azfar Farogh · Phase 4, Interventional, and Treatment
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.
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.
193 studies on the registry are indexed under Peptic Ulcer; 31 are open to participants now.
This study's enrollment of 752 is above the median of 150 across 142 interventional studies indexed under Peptic Ulcer.
Browse Peptic Ulcer studies →This is the only study on the registry with Azfar Farogh as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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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Participants received Omeprazole 40 mg twice daily, Amoxicillin 1 g twice daily, and Clarithromycin 500 mg twice daily for 14 days.
Drug: Triple Therapy
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.
Drug: Quadruple Therapy
Omeprazole 40 mg BID, Amoxicillin 1 g BID, Clarithromycin 500 mg BID for 14 days.
Omeprazole 40 mg BID, Metronidazole 400 mg TID, Tetracycline 500 mg QID, Bismuth subsalicylate for 14 days.
Eradication of Helicobacter pylori infection six weeks post-treatment
Eradication was assessed by stool antigen testing six weeks after completion of therapy. A negative stool antigen test indicated successful eradication.
Time frame: 6 weeks after treatment completion
Plan to share: No
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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