Levofloxacin-Based Sequential Therapy Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication

Levofloxacin-Based Sequential Therapy Compared With Bismuth-Based Quadruple Therapy for Eradication of Helicobacter Pylori Infection: A Randomized Controlled Trial

This randomized controlled trial aims to compare the efficacy and safety of levofloxacin-based sequential therapy versus bismuth-based quadruple therapy for eradication of Helicobacter pylori infection in adult patients. Helicobacter pylori infection remains highly prevalent in developing countries and is associated with gastritis, peptic ulcer disease, mucosa-associated lymphoid tissue lymphoma, and gastric cancer. Increasing antibiotic resistance has reduced the effectiveness of conventional treatment regimens, creating a need for alternative first-line therapies with improved eradication rates and acceptable tolerability.

Eligible adult patients diagnosed with H. pylori infection by stool antigen testing will be recruited from the Gastroenterology Department of Services Hospital Lahore. Participants will be randomly assigned in a 1:1 ratio to receive either levofloxacin-based sequential therapy or bismuth-based quadruple therapy for 14 days.

The primary outcome of the study is successful eradication of H. pylori infection, confirmed by stool antigen testing performed 6 weeks after completion of therapy. Secondary outcomes include treatment-related adverse effects, treatment compliance, and overall treatment cost.

The study aims to identify an effective and affordable treatment strategy for H. pylori eradication in a population with high antibiotic resistance and socioeconomic limitations.

Inclusion Criteria:

• Adults aged 20 years and older
• Confirmed Helicobacter pylori infection by stool antigen testing
• Willingness to comply with the assigned treatment regimen
• Ability to provide informed consent
• Willingness to complete follow-up evaluation

Exclusion Criteria:

• Use of antibiotics within 4 weeks prior to enrollment
• Active gastrointestinal infection other than Helicobacter pylori
• Previous gastrointestinal tract surgery
• Pregnant or lactating females
• Known allergy or intolerance to study medications
• Psychiatric illness or other condition impairing treatment compliance
• Severe comorbid illness making participation unsuitable in the investigator's judgment