Helicobacter Pylori Infection Occurrence in Russia

Helicobacter Pylori Infection Occurrence in Primary Care Settings 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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Diagnostic test: 13-C urea breath test

• Study Type: Observational
• Enrollment (Actual): 70000

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 111123
    • Moscow Clinical Scientific Center
  • Moscow, Russian Federation, 115446
    • Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment-naïve; Subjects without previous experience of treatment provided for H.pylori infection	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.
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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
• Collaborators: St. Petersburg State Pavlov Medical University; Moscow Clinical Scientific Center; People's Friendship University of Russia
• Investigators: Principal Investigator: Dmitry Bordin, MD, PhD, Professor, Moscow Clinical Scientific Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: May 13, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: May 17, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Helicobacter pylori; prospective trial; occurrence; ambulatory settings
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Helicobacter Infections
• Other Study ID Numbers: АААА-А18-118021590202-9 (Registry Identifier: NIOKTR ROSRID); АААА-А17-117080910167-9 (Registry Identifier: NIOKTR ROSRID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Depersonalised data will be available upon request
• IPD Sharing Time Frame: Upon request
• IPD Sharing Access Criteria: reasonable request to the principal investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No