Helicobacter Pylori Infection Occurrence in Russia

Study Overview
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Brief Summary
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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.

Official Title
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Helicobacter Pylori Infection Occurrence in Primary Care Settings in Russia

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Diagnostic Test: 13-C urea breath test


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment-naïve<br>Subjects without previous experience of treatment provided for H.pylori infection | Diagnostic Test: 13-C urea breath test<br>* 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.<br>|
| treatment experienced<br>Subjects who were previously tested positive for H.pylori infection and who were treated for H.pylori infection with at least 2 antibiotics in combination with proton pump inhibitor not less than 6 weeks before the 13C-urea breath test | Diagnostic Test: 13-C urea breath test<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of H.pylori infection | Delta over the baseline (δ) of 13C/12C based on the results of the initial and second samples ≥4.0‰ are positive | during the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, occurrence, ambulatory settings, prospective trial