Status:
UNKNOWN
Prospective Randomised Trial of First and Second Line Treatments of RCT of First and Second Line H Pylori Treatments in Slovenia
Lead Sponsor:
Slovenian Society for Gastroenterology and Hepatology
Collaborating Sponsors:
KRKA
Conditions:
Helicobacter Pylori Infection
Eradication Treatments
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Study is prospective randomised multicentric. The primary objective of the study is to compare the efficacy of two first-line therapy regimens and two second-line therapy regimens (ie, after failure o...
Detailed Description
The infection with Helicobacter pylori is extremely widespread, as 60% of the world's population is infected. In Slovenia, the average prevalence is 25.1 %, the prevalence in the 20-year age group is ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients 18 to 80 years of age.
- Patients have not received proton pump inhibitors for the past 14 days.
- Patients did not receive antibiotics in the last month.
- Helicobacter pylori infection has been demonstrated by rapid urease test.
- Exclusion Criteria:
- Prior treatment for Helicobacter pylori infection (in patients who will receive Schedule 1 eradication therapy).•
- Defects in blood clotting. taking anticoagulant medicines that make it impossible to take biopsies.
- Allergy to drugs used in the study.
- Pregnancy, breastfeeding shold be excluded.
- Psychiatric illness that would prevent research participation.
- Active treatment for malignancy.
Exclusion
Key Trial Info
Start Date :
May 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2023
Estimated Enrollment :
560 Patients enrolled
Trial Details
Trial ID
NCT04359966
Start Date
May 10 2020
End Date
September 30 2023
Last Update
April 24 2020
Active Locations (3)
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1
DC BLED
Bled, Slovenia, 4260
2
UCC
Ljubljana, Slovenia, 1000
3
Am Dc Rogaska
Rogaška Slatina, Slovenia, 3250