Comparing two treatments for Helicobacter pylori infection
Efficacy of Amoxicillin-Esomeprazole High Dose Dual Therapy Compared to Levofloxacin Containing Triple Therapy for the Eradication of Helicobacter Pylori in a Tertiary Care Hospital: A Single-blind Randomized Controlled Trial
PHASE4 · Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · NCT06088316
This study is testing whether a higher dose of amoxicillin and esomeprazole works better than a combination of amoxicillin, levofloxacin, and esomeprazole to treat stomach infections caused by Helicobacter pylori in people with digestive issues.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh (other) |
| Locations | 1 site (Dhaka) |
| Trial ID | NCT06088316 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of amoxicillin-esomeprazole high dose dual therapy versus levofloxacin triple therapy in treating dyspeptic patients infected with Helicobacter pylori. Participants will be screened using stool antigen tests and endoscopy with rapid urease tests to confirm infection. Those who test positive will be randomized into two groups, with one receiving a higher dose of amoxicillin and esomeprazole, while the other receives a standard dose of amoxicillin, levofloxacin, and esomeprazole for 14 days. The study will also monitor dyspeptic symptoms and side effects throughout the treatment period.
Who should consider this trial
Good fit: Ideal candidates for this study are dyspeptic patients aged 18 and older who test positive for Helicobacter pylori infection.
Not a fit: Patients who have received prior treatment for Helicobacter pylori or have certain advanced comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from Helicobacter pylori infections, potentially reducing the risk of serious gastrointestinal diseases.
How similar studies have performed: Other studies have shown varying success with different treatment regimens for Helicobacter pylori, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Dyspeptic patients with positive Rapid urease test \& stool antigen test 3. patients giving written informed consent Exclusion Criteria: 1. Treatment with proton pump inhibitor, H2-receptor antagonist, bismuth preparation within the last 2 weeks or antibiotics within 4 weeks prior to study. 2. Previous H. pylori eradication therapy 3. Complicated duodenal ulcer patients (active bleeding and perforation) 4. Patients with regular intake of NSAIDs or steroids. 5. Surgery that might affect gastric acid secretion (upper GI resection or vagotomy) 6. Known case of malignancy 7. Advanced Co-morbidities (e.g. CLD, CKD, cardio-respiratory failure, known thyroid disease) 8. participants who are pregnant, lactating or intend to become pregnant within the duration of the study.
Where this trial is running
Dhaka
- Bangabandhu sheikh mujib medical university — Dhaka, Bangladesh (RECRUITING)
Study contacts
- Principal investigator: Salman Rafat, Mbbs — Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Study coordinator: Salman Rafat, Mbbs
- Email: salmanrafat08@gmail.com
- Phone: +88019996936611
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Helicobacter Pylori Infection, Helicobacter Pylori Eradication, Helicobacter pylori, Dyspepsia