NCT04892238

Helicobacter Pylori Infection Occurrence in Russia

Helicobacter Pylori Infection Occurrence in Primary Care Settings in Russia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70,000 (actual)
• Sponsor: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

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.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	13-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.

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-12-31
• Completion: 2020-07-31
• First posted: 2021-05-19
• Last updated: 2021-05-19

Locations

2 sites across 1 country: Russia