Status:
COMPLETED
Helicobacter Pylori Infection Occurrence in Russia
Lead Sponsor:
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Collaborating Sponsors:
Moscow Clinical Scientific Center
St. Petersburg State Pavlov Medical University
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
12+ years
Brief Summary
This study is planned to reveal the occurrence rate of H.pylori infection in ambulatory settings' patients in Russia and to compare the occurrence rates in different years in treatment-naïve and previ...
Eligibility Criteria
Inclusion
- willingness to participate (based on the signed informed consent form);
- age older than 12 y.o. (for subjects younger than 18 y.o. written informed consent of a legal representative was obligatory);
- availability of demographic data and medical history, including previous treatment for H.pylori infection
- For subjects of "treatment-naïve" group:
- no previous treatment for H.pylori infection in the anamnesis;
- at least 6 weeks after previous use of any antimicrobial agents for any reason;
- at least 2 weeks' time frame free of use of proton pump inhibitors, other anti-secretory agents and bismuth preparations.
- For "Previously treated" group of subjects:
- infection caused by H.pylori established earlier and
- not less than 6 weeks after the end of eradication therapy with at least 2 antibiotics and a proton pump inhibitor for at least 7 days, based on a patient's report
Exclusion
- history of surgery on chest, stomach, gut (excluding appendectomy or laparoscopic cholecystectomy performed more than 6 month before the enrolment);
- advanced stage of chronic obstructive pulmonary disease,
- allergies to citruses,
- pregnant and breastfeeding women.
Key Trial Info
Start Date :
January 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2020
Estimated Enrollment :
70000 Patients enrolled
Trial Details
Trial ID
NCT04892238
Start Date
January 1 2017
End Date
July 31 2020
Last Update
May 19 2021
Active Locations (2)
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1
Moscow Clinical Scientific Center
Moscow, Russia, 111123
2
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Moscow, Russia, 115446