Helicobacter Pylori Infection Occurrence in Russia

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Diagnostic Test: 13-C urea breath test

• Registration Number: NCT04892238
• Lead Sponsor: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-07-31
• Status Verified: 2021-05
• Study First Submitted: 2021-05-13
• Study First Submitted QC: 2021-05-17
• Last Update Submitted: 2021-05-17
• Study First Posted: 2021-05-19
• Last Update Posted: 2021-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
treatment experienced	13-C urea breath test	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
Treatment-naïve	13-C urea breath test	Subjects without previous experience of treatment provided for H.pylori infection

Primary Outcome Measures

Name	Time	Method
Presence of H.pylori infection	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

Trial Locations

Locations (2)

Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology; 🇷🇺 Moscow, Russian Federation

Moscow Clinical Scientific Center; 🇷🇺 Moscow, Russian Federation