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

Official title

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

Overview

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.

Interventions

• Other Levofloxacin-Based Sequential Therapy
  Participants will receive a 14-day levofloxacin-based sequential therapy regimen. During days 1-7, participants will receive dexlansoprazole 60 mg twice daily and amoxicillin 1 g twice daily. During days 8-14, participants will receive dexlansoprazole 60 mg twice daily, levofloxacin 500 mg once daily, and tinidazole 500 mg twice daily.
• Other Bismuth-Based Quadruple Therapy
  Participants will receive a 14-day bismuth-based quadruple therapy regimen consisting of bismuth subsalicylate 265 mg (two tablets) twice daily, dexlansoprazole 60 mg twice daily, doxycycline 100 mg twice daily, and tinidazole 500 mg twice daily.

Primary outcome measures

• Helicobacter pylori Eradication Rate [Time frame: 6 weeks after completion of therapy]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07574983 · 156

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗