Helicobacter Pylori Infection Occurrence in Russia

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

Status: Completed

Conditions: Helicobacter Pylori Infection

Treatments: Diagnostic Test: 13-C urea breath test

Study type: Observational

Funder types: Other

Identifiers

NCT04892238

АААА-А17-117080910167-9 (Registry Identifier)

АААА-А18-118021590202-9 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 70,000 patients

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

70,000 participants in 2 patient groups

Treatment-naïve

Description:

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

Treatment:

Diagnostic Test: 13-C urea breath test

treatment experienced

Description:

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:

Diagnostic Test: 13-C urea breath test