Tailored Vs. Empirical Helicobacter Pylori Infection Treatment

Launched by MANUEL COELHO DA ROCHA · Dec 30, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on finding the best way to treat Helicobacter pylori (H. pylori) infections, which are common bacteria that can lead to stomach problems like ulcers and even cancer. The study will compare two treatment approaches: one that is tailored based on specific tests showing which antibiotics will work best for each patient, and another that uses a standard treatment method without those tests. The goal is to see if the tailored approach is just as effective and safe as the standard treatment, which is important because antibiotic resistance is becoming a major issue.

To participate in this trial, you need to be over 18 years old and scheduled for an upper GI endoscopy to take stomach biopsies. However, there are some exclusions, such as if you have taken certain medications recently, have a serious health condition, or are pregnant or breastfeeding. If you join, you will be monitored to see how well the treatments work, and the findings may lead to improved recommendations for treating H. pylori infections in the future. This is the first national study of its kind in Portugal, aiming to make a real impact on how these infections are treated.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Individuals older than 18 years old scheduled for upper GI endoscopy with indication for gastric biopsies (clinical or endoscopic findings)
• Exclusion Criteria:
• • 1st phase (clinical): patients who had received antimicrobial therapy 1 month prior to endoscopy; patients who had received proton pump inhibitor (PPI) therapy 2 weeks prior to endoscopy; patients who had ever received H. pylori eradication therapy (despite its efficacy); history of previous gastrectomy; non-Portuguese nationality; pregnant or breastfeeding women; women of childbearing age without effective contraception; suspected or documented allergy to amoxicillin; serious comorbidities (ASA 3 or more); ongoing medication with anticoagulants
• • 2nd phase (endoscopic): upper GI tract neoplasia; hemorrhagic gastritis; upper GI tract varices
• • 3rd phase (pathological): H. pylori negative patients