Non-invasive Test-guided Tailored Therapy Versus Empiric Treatment for Helicobacter Pylori Infection.

• Status: Recruiting
• Trial end date: 2022-04-14
• Target enrollment: 0
• Participant gender: All

Summary

The aim of our study will be to assess in an open-label, multicenter, randomized controlled trial whether a tailored therapy guided by a non-invasive antibiotic susceptibility test on stool samples achieves higher Helicobacter eradication rates than an empiric antibiotic regimen. For this purpose, consecutive patients with dyspeptic symptoms, diagnosis of Helicobacter pylori infection and naïve to eradicating treatments will be allocated to either of the two intervention arms.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Bari
• Treatments: Amoxicillin; Anti-Bacterial Agents; Bismuth; Bismuth tripotassium dicitrate; Clarithromycin; Levofloxacin; Metronidazole; Ofloxacin; Pantoprazole; Rifabutin; Tetracycline

Criteria

Inclusion Criteria:

• presence of dyspeptic symptoms, according to Rome IV criteria;

• Helicobacter pylori infection diagnosis by the positivity of at least 2 out of 4 diagnostic tests (i.e. histology, rapid urease test, urea breath test, and serology);

• naive to Helicobacter pylori treatment;

• written informed consent.

Exclusion Criteria:

• previous Helicobacter pylori treatment;

• diagnosis of gastric cancer or other diseases requiring surgery;

• contraindications to upper endoscopy;

• chronic diarrhea;

• known allergy to any drugs used in the intervention and control arm.