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NCT Number: NCT07574983

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levofloxacin-Based Sequential Therapy

Other

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.

Bismuth-Based Quadruple Therapy

Other

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 outcomes

  1. Helicobacter pylori Eradication Rate

    Time frame: 6 weeks after completion of therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Tanveer Principal Investigator

CONTACT

[email protected]

030708693386

Sponsors and collaborators

Lead sponsor

University of Health Sciences Lahore

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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