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Comparison of the effectiveness of triple and quadruple therapy regimens for Helicobacter pylori eradication in patients with positive stool antigen test

Comparison of the effectiveness of triple and quadruple therapy regimens for Helicobacter pylori eradication in patients with positive stool exam: A randomized, single-blind clinical trial study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250227064868N1
Enrollment
126
Registered
2025-05-02
Start date
2025-04-05
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H.pilory infection. Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere

Interventions

Intervention 1: Intervention group: Treatment regimen A for 14 days containing PPI: Esomeprazole 40 mg BID (Abidi Pharmaceutical Company) - Amoxicillin: 1000 mg TDS (Subhan Pharmaceutical Company) -

Sponsors

Shahre-kord University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Helicobacter pylori positive Patients with first attempt at Helicobacter pylori eradication Age over 18 years

Exclusion criteria

Exclusion criteria: previous treatment for Helicobacter pylori eradication pregnancy or breastfeeding previous treatment for eradication of Helicobacter pylori malignant neoplasms history of gastrectomy history of allergy or adverse reactions to the study drugs history of use of PPIs and Potassium-Competitive Acid Blockers in the 2 weeks prior to randomization hematological disease, central nervous system infection, infectious mononucleosis, glucose-galactose malabsorption, lactase deficiency, galactose intolerance, or torsades de pointes Concomitant use of drugs that may interact with the drugs in the present study Withdrawal of consent or failure to complete the final test follow-up Development of drug hypersensitivity or intolerable adverse effects

Design outcomes

Primary

MeasureTime frame
The eradication rate of Helicobacter pylori, which is defined as a negative stool antigen test. Timepoint: The stool antigen test is performed at the beginning of the study (before the intervention as an inclusion criterion) and four weeks after the completion of treatment. Method of measurement: Stool Antigen Test.

Secondary

MeasureTime frame
Adherence to treatment. Timepoint: Four weeks after the completion of treatment. Method of measurement: Direct questioning of the patient and writing on the checklist.;The clinical symptoms of patients (pain, bloating, appetite, heartburn) and the incidence of side effects during treatment as reported by the patients. Timepoint: After the completion of treatment. Method of measurement: Direct questioning of the patient and writing on the checklist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Sanei Dehkordi

Shahre-kord University of Medical Sciences

sanei@skums.ac.ir+98 38 3222 8693

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026