Helicobacter Pylori Infection Occurrence in Russia

NCT04892238 | Completed DMC

• 2 other identifiers: АААА-А18-118021590202-9АААА-А17-117080910167-9
• Study Type: observational
• Target: 70,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; occurrence; ambulatory settings; prospective trial

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Treatment-naïve

Subjects without previous experience of treatment provided for H.pylori infection

Diagnostic Test: 13-C urea breath test

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

Interventions

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.

Treatment-naïve; treatment experienced

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology: lead
• Moscow Clinical Scientific Center: collaborator
• St. Petersburg State Pavlov Medical University: collaborator
• People's Friendship University of Russia: collaborator

Study Sites (2)

Moscow Clinical Scientific Center

Moscow, 111123, Russia

Location

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

Moscow, 115446, Russia

Location

Related Publications (1)

• 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.

  PMID: 35971900 DERIVED

Study Officials

• Dmitry Bordin, MD, PhD, Professor

  Moscow Clinical Scientific Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Leading researcher

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: May 19, 2021
• Study Start: January 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: July 31, 2020
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Upon request
• Access Criteria: reasonable request to the principal investigator

Locations

RU (2)