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

NCT07574983 | Not Yet Recruiting

• 1 other identifier: 156
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

HELICOBACTER PYLORI INFECTIONS

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori Eradication Rate

  6 weeks after completion of therapy

Study Arms (2)

Levofloxacin-Based Sequential Therapy

EXPERIMENTAL

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

Bismuth-Based Quadruple Therapy

ACTIVE COMPARATOR

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

Interventions

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.

Levofloxacin-Based Sequential Therapy

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.

Bismuth-Based Quadruple Therapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

Central Study Contacts

Tanveer Principal Investigator

CONTACT

030708693386; tenu9428@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 2, 2026
• First Posted: May 8, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05