Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori, occurrence, ambulatory settings, prospective trial
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 previously treated subjects.
Interventions
DIAGNOSTIC_TEST13-C urea breath test
Standard urea breath test (UBT) (HELICARB, LLC ISOCARB, reg. cert. #РЗН 2016/3773 issued by Roszdravnadzor on 29.02.2016) with 13C-carbamide of 99% purity used for the study. Samples of exhaled air obtained before and after 20 minutes after 50 mg 13C-urea intake are analysed for 13C/12C isotope ratio with the use of infrared spectrometer IRIS.Doc (Kibion, Sweden). Delta over baseline (δ) of 13C / 12C is calculated based on the results of the initial and second samples, the results were shown in ppm (‰). The results of the test is negative if δ was \<4.0‰; test results with δ ≥4.0‰ are considered positive.
Sponsors
Moscow Clinical Scientific Center
St. Petersburg State Pavlov Medical University
People's Friendship University of Russia
Federal State Budgetary Scientific Institution Federal Research Centre of Nutrition, Biotechnology
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of H.pylori infection | during the procedure | Delta over the baseline (δ) of 13C/12C based on the results of the initial and second samples ≥4.0‰ are positive |
Countries
Russia
Outcome results
None listed