Comparative Effectiveness of Triple Versus Quadruple Therapy in the Treatment of Helicobacter Pyl… (NCT07312721) | Clinical Trial Compass
CompletedPhase 4
Comparative Effectiveness of Triple Versus Quadruple Therapy in the Treatment of Helicobacter Pylori Induced Gastritis
Pakistan752 participantsStarted 2024-01-05
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Eradication of Helicobacter pylori infection six weeks post-treatment