Status:
NOT_YET_RECRUITING
Tailored Vs. Empirical Helicobacter Pylori Infection Treatment
Lead Sponsor:
Manuel Coelho da Rocha
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Helicobacter pylori (Hp) is a gram-negative bacterium that colonizes human gastric mucosa and is associated with chronic gastritis that can progress to severe complications such as peptic ulcer diseas...
Detailed Description
A prospective, multicenter, randomized, controlled interventional trial in two arms: intervention group and control group. Eligible patients will receive oral and written information and will be enro...
Eligibility Criteria
Inclusion
- Individuals older than 18 years old scheduled for upper GI endoscopy with indication for gastric biopsies (clinical or endoscopic findings)
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06200779
Start Date
September 1 2025
End Date
December 1 2026
Last Update
December 20 2024
Active Locations (1)
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1
Unilabs Portugal
Porto, Porto District, Portugal, 4150-178