Clinical trial NCT04892238: Helicobacter Pylori Infection Occurrence in Russia
Official title: Helicobacter Pylori Infection Occurrence in Primary Care Settings in Russia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
occurrence
ambulatory settings
prospective trial
Lead sponsor: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Sponsor class: OTHER
Collaborators: name: Moscow Clinical Scientific Center
name: St. Petersburg State Pavlov Medical University
name: People's Friendship University of Russia
First posted: 2021-05-19
Enrollment: 70000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Presence of H.pylori infection
timeFrame: during the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow Clinical Scientific Center
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Study officials:
affiliation: Moscow Clinical Scientific Center
name: Dmitry Bordin, MD, PhD, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.