Actively Recruiting
Evaluating the Effectiveness of Anti-Ulcerants (Dexlansoprazole, Lansoprazole, and Vonoprazan) With Levofloxacin-Based Triple Therapy for Helicobacter Pylori Eradication - A Three-arm Randomized Controlled Trial
Led by Dow University of Health Sciences · Updated on 2026-01-15
942
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the effectiveness of three different proton pump inhibitors (PPIs) combined with Levofloxacin and Amoxicillin for treating Helicobacter pylori infections. H. pylori is a widespread infection that can cause stomach inflammation, ulcers, and increase the risk of stomach cancer, especially in regions with high antibiotic resistance like Pakistan. The study is a Phase 4, randomized controlled trial involving adult patients diagnosed with H. pylori who are not currently receiving treatment. Participants will be randomly assigned to one of three treatment groups: Dexlansoprazole 60mg twice daily, Lansoprazole 30mg twice daily, or Vonoprazan 20mg twice daily, each combined with Levofloxacin 500mg once daily and Amoxicillin 1g twice daily for 14 days. The study will take place over 12 months at multiple healthcare centers across Pakistan. The main goal is to measure how well each treatment eradicates H. pylori infection, with follow-up assessments six weeks after treatment. During the study, participants will complete questionnaires about their gastrointestinal symptoms using the Gastrointestinal Symptom Rating Scale (GSRS) at the start and after treatment. The success of eradication will be measured by a Urea Breath Test (UBT) at follow-up. Researchers will also monitor any side effects and treatment adherence. Statistical analysis will compare eradication rates and symptom improvements among the three treatment groups, helping to identify the most effective therapy for this infection in high-resistance settings.
CONDITIONS
Brief Title
CURE-H. Pylori: A Trial on the Combination of Anti-Ulcerants and Levofloxacin-Based Therapy for Helicobacter Pylori Eradication
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older of both sexes
- Diagnosed with Helicobacter pylori infection through a Urea Breath Test
- Not currently receiving treatment for Helicobacter pylori infection
You will not qualify if you...
- Patients who do not provide written consent
- Patients with severe mental disability
- Pregnant or lactating women
- Patients already on treatment for Helicobacter pylori infection
- Patients who have taken any antibiotic within two weeks before enrolling
- Patients with known allergies to the study drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants receive a 14-day course of a combination drug therapy involving Dexlansoprazole, Lansoprazole, or Vonoprazan with Levofloxacin and Amoxicillin to eradicate Helicobacter pylori infection.
1 baseline visit to start treatment
Duration - Approximately 6 weeks post-treatment
Participants return approximately six weeks after completing treatment for assessment of H. pylori eradication via Urea Breath Test and evaluation of gastrointestinal symptom improvement.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Sindh Institute of Advanced Endoscopy and Gastroenterology (SIAG), DUHS
Karachi, Pakistan, 75600
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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