Helicobacter Pylori InfectionNCT04892238
Helicobacter Pylori Infection Occurrence in Russia
An observational study of Helicobacter Pylori Infection, run by Federal State Budgetary Scientific Institution at 2 sites in Russia.
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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- 13-C urea breath test
- How many people
- 70,000 participants
- Where
- 2 sitesRussia
- Study dates
- 1 Jan 2017to 31 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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;
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- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Russia2 sites
Moscow Clinical Scientific Center
Moscow, 111123
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Moscow, 115446
About this study
Official title: Helicobacter Pylori Infection Occurrence in Primary Care Settings in Russia
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
- Being tested
- 13-C urea breath test
- Keywords
- Helicobacter pylori, occurrence, ambulatory settings, prospective trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13-C urea breath testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment-naïve | Subjects without previous experience of treatment provided for H.pylori infection Receives: 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 Receives: Diagnostic Test: 13-C urea breath test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start1 Jan 2017
- Primary completion31 Dec 2019
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Scientific Institution
- Sponsor type
- Other government
- Collaborators
- Moscow Clinical Scientific Center, St. Petersburg State Pavlov Medical University, People's Friendship University of Russia
- Responsible party
- Principal investigator, Sergey Morozov, Federal State Budgetary Scientific Institution
- Investigators
- Dmitry Bordin, MD, PhD, Professor, Principal investigator, Moscow Clinical Scientific Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892238
- Sponsor's protocol ID
- АААА-А18-118021590202-9
- Other IDs
- АААА-А18-118021590202-9, АААА-А17-117080910167-9
- Status last verified
- May 2021
- First submitted
- 13 May 2021
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Depersonalised data will be available upon request
Publications
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.
PubMed 35971900
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helicobacter Pylori Infection Occurrence in Primary Care Settings in Russia
- ClinicalTrials.gov ID
- NCT04892238
- Acronym / sponsor ID
- АААА-А18-118021590202-9
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, occurrence, ambulatory settings, prospective trial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70,000 participants (actual)
- Lead sponsor
- Federal State Budgetary Scientific InstitutionOther government
- Collaborators
- Moscow Clinical Scientific Center, St. Petersburg State Pavlov Medical University, People's Friendship University of Russia
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment-naïve | – | Diagnostic Test: 13-C urea breath testSubjects without previous experience of treatment provided for H.pylori infection |
| treatment experienced | – | Diagnostic Test: 13-C urea breath testSubjects 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 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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
- no previous treatment for H.pylori infection in the anamnesis;
- at least 6 weeks after previous use of any antimicrobial agents for any reason;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 13-C urea breath testStandard 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. | Diagnostic test | Treatment-naïve, treatment experienced |
Primary outcome
Presence of H.pylori infection
Time frame: during the procedure
Delta over the baseline (δ) of 13C/12C based on the results of the initial and second samples ≥4.0‰ are positive
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Derived from this study: PubMed 35971900Bordin 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.
- Individual participant dataSharing planned: Yes. Depersonalised data will be available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dmitry Bordin, MD, PhD, Professor principal investigator
Moscow Clinical Scientific Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Infection, run by Federal State Budgetary Scientific Institution at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of H.pylori infection (time frame: during the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04892238, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.