Helicobacter Pylori Infection Occurrence in Russia

NCT04892238 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70000

Last updated 2021-05-19

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Moscow Clinical Scientific Center

    collaborator OTHER
  • St. Petersburg State Pavlov Medical University

    collaborator OTHER
  • People's Friendship University of Russia

    collaborator OTHER
  • Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

    lead OTHER

Principal Investigators

  • Dmitry Bordin, MD, PhD, Professor · Moscow Clinical Scientific Center

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2019-12-31
Completion
2020-07-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04892238 on ClinicalTrials.gov