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.

Study Overview

• Status: Not yet recruiting
• Conditions: HELICOBACTER PYLORI INFECTIONS
• Intervention / Treatment: Other: Levofloxacin-Based Sequential Therapy; Other: Bismuth-Based Quadruple Therapy

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tanveer Principal Investigator; Phone Number: 030708693386; Email: tenu9428@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Levofloxacin-Based Sequential Therapy; Participants assigned to this arm will receive levofloxacin-based sequential therapy for 14 days. 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: 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.
Active Comparator: Bismuth-Based Quadruple Therapy; Participants assigned to this arm will receive bismuth-based quadruple therapy for 14 days, consisting of bismuth subsalicylate 265 mg (two tablets) twice daily, dexlansoprazole 60 mg twice daily, doxycycline (Vibramycin) 100 mg twice 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Helicobacter pylori Eradication Rate	6 weeks after completion of therapy

Collaborators and Investigators

• Sponsor: University of Health Sciences Lahore

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: May 2, 2026
• First Submitted That Met QC Criteria: May 2, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 2, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 156

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No