Helicobacter Pylori Infection Occurrence in Russia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2020-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Helicobacter Pylori Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment-naïve

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

13-C urea breath test

Intervention Type 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 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

13-C urea breath test

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes