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Completed

NCT Number: NCT04892238

Helicobacter Pylori Infection Occurrence in Russia

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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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology, Moscow, Russia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Presence of H.pylori infection

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Federal State Budgetary Scientific Institution

Other Gov

Collaborators

  • Moscow Clinical Scientific Center
  • People's Friendship University of Russia
  • St. Petersburg State Pavlov Medical University

Registry information

Official study title

Helicobacter Pylori Infection Occurrence in Primary Care Settings in Russia

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
May 19, 2021
Registry last updated
May 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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