Status:
UNKNOWN
Non-invasive Test-guided Tailored Therapy Versus Empiric Treatment for Helicobacter Pylori Infection.
Lead Sponsor:
University of Bari
Conditions:
Helicobacter Pylori Infection
Antibiotic Resistant Infection
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 ac...
Detailed Description
Study design: Eligible subjects will be defined by the positivity to at least 2 out of 4 tests for Helicobacter pylori infection diagnosis (i.e. histology, rapid urease test, urea breath test and ser...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 14 2022
Estimated Enrollment :
362 Patients enrolled
Trial Details
Trial ID
NCT04107194
Start Date
January 14 2020
End Date
April 14 2022
Last Update
January 12 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Michele Barone
Bari, BA, Italy, 70124