Helicobacter Pylori Infection Occurrence in Russia

Helicobacter Pylori Infection Clinical Trial

Official title:

Helicobacter Pylori Infection Occurrence in Primary Care Settings in Russia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04892238
• Other study ID #: ????-?18-118021590202-9
• Secondary ID: ????-?18-1180215
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: July 31, 2020

Study information

• Verified date: May 2021
• Source: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70000
• Est. completion date: July 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection

Intervention

Diagnostic Test:
• 13-C urea breath test
Standard urea breath test (UBT) ("HELICARB", LLC "ISOCARB", reg. cert. #??? 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 (d) 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 d was <4.0‰; test results with d =4.0‰ are considered positive.

Locations

Country	Name	City	State
Russian Federation	Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology	Moscow
Russian Federation	Moscow Clinical Scientific Center	Moscow

Sponsors (4)

Lead Sponsor	Collaborator
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology	Moscow Clinical Scientific Center, People's Friendship University of Russia, St. Petersburg State Pavlov Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of H.pylori infection	Delta over the baseline (d) of 13C/12C based on the results of the initial and second samples =4.0‰ are positive	during the procedure