First Report of National Consensus Guidelines for the Diagnosis and Treatment of Helicobacter pylori Infection in Iran.

Abstract

Background: Helicobacter pylori infection remains a major public health concern in Iran, where high prevalence, alarming antibiotic resistance, and significant gastric cancer burden necessitate a unified and evidence-based national strategy. Despite the availability of international guidelines, gaps in clinical practice persist due to local epidemiology, resistance patterns, and diagnostic challenges. This study presents the first national Iranian consensus guideline for the diagnosis and management of H. pylori infection.

Methods: A multidisciplinary panel of experts from leading Iranian gastroenterology centers convened between August 2023 and October 2025. Using the GRADE framework, the scientific committee conducted systematic literature reviews and formulated evidence-based statements across diagnostic, therapeutic, and clinical management domains. Consensus was defined as ≥ 80% agreement. Twelve structured meetings, including a final hybrid national consensus conference, were held to refine recommendations.

Results: The guideline delivers 35 evidence-graded statements addressing indications for testing and treatment, optimal diagnostic modalities, and treatment pathways. Key recommendations include a strong preference for non-invasive testing in patients under 45 without alarm features, endoscopic evaluation with targeted biopsies in high-risk groups, and confirmation of eradication using urea breath test (UBT) or monoclonal stool antigen test (SAT) at ≥ 4 weeks post-treatment. Given Iran's high clarithromycin resistance (> 20%), a course of 10-14 days bismuth quadruple therapy (BQT) is recommended as first-line treatment, with non-bismuth concomitant therapy as an alternative. Susceptibility-guided therapy is encouraged when feasible, particularly after treatment failure. High-dose proton pump inhibitor (PPI) or potassium competitive acid blocker (P-CAB)-based acid suppression is emphasized to enhance eradication efficacy. Special considerations are provided for renal/hepatic impairment and drug interactions.

Conclusion: This national guideline provides a standardized, evidence-based framework for improving H. pylori diagnosis and management. By integrating local antimicrobial resistance patterns and practical clinical considerations, the guideline helps optimize eradication rates, reinforce antibiotic stewardship, and contribute to gastric cancer prevention efforts across Iran.