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| ID | Type | Description | Link |
|---|---|---|---|
| АААА-А18-118021590202-9 | Registry Identifier | NIOKTR ROSRID | |
| АААА-А17-117080910167-9 | Registry Identifier | NIOKTR ROSRID |
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| Name | Class |
|---|---|
| Moscow Clinical Scientific Center | OTHER |
| St. Petersburg State Pavlov Medical University | OTHER |
| People's Friendship University of Russia | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment-naïve | Subjects without previous experience of treatment provided for H.pylori infection |
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| treatment experienced | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13-C urea breath test | Diagnostic 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. |
| 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 |
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Inclusion Criteria:
For subjects of "treatment-naïve" group:
For "Previously treated" group of subjects:
Exclusion Criteria:
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Ambulatory subjects, referred to perform urea breath test (UBT) and who gave written informed consent for the use of their data for research purposes are aligible for the study.
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| Name | Affiliation | Role |
|---|---|---|
| Dmitry Bordin, MD, PhD, Professor | Moscow Clinical Scientific Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moscow Clinical Scientific Center | Moscow | 111123 | Russia | |||
| Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35971900 | Derived | Bordin D, Morozov S, Plavnik R, Bakulina N, Voynovan I, Skibo I, Isakov V, Bakulin I, Andreev D, Maev I. Helicobacter pylori infection prevalence in ambulatory settings in 2017-2019 in RUSSIA: The data of real-world national multicenter trial. Helicobacter. 2022 Oct;27(5):e12924. doi: 10.1111/hel.12924. Epub 2022 Aug 16. |
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Depersonalised data will be available upon request
Upon request
reasonable request to the principal investigator
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| Moscow |
| 115446 |
| Russia |