Clinical trial · Observational
Epidemiology of Helicobacter Pylori Infection in Moscow
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
H. pylori is transmitted from individual to individual and causes chronic active gastritis in all infected people. H. pylori infection can result in gastroduodenal ulcers, atrophic gastritis (AG), gastric carcinoma, and gastric MALT lymphoma. More than 90% of gastric carcinomas are linked to H. pylori infection that causes chronic AG. A long course of the disease leads to the loss of gastric glands (chronic AG) followed by gastric intestinal metaplasia (GIM), dysplasia, and cancer. This defines two cancer prevention strategies: primary that consists of detection and eradication of H. pylori and secondary that focuses on endoscopic screening for pre-neoplastic lesions and follow-up. Primary prevention planning requires reliable information on the H. pylori prevalence in the population. To design secondary prevention measures, an understanding of the age-sex structure of precancerous changes in the gastric mucosa (the prevalence of atrophic gastritis) is necessary. H. pylori eradication is the basis of primary prevention of gastric cancer (GC). Approximately 36,000 new cases of GC are registered in the Russian Federation each year, and more than 34,000 patients die from the disease. Men get sick 1.3 times more often than women, the peak incidence occurs at the age of over 50 years. The poor outcomes reflect the late stage of diagnosis of this potentially preventable and treatable cancer. The lack of up-to-date data on the H. pylori prevalence in Moscow hinders developing of measures for the detection and timely treatment of this infection as well as the reduction of GC morbidity and mortality.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Atrophy | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Helicobacter Pylori Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OLGA and H.pylori culture | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1
- description
- Screening for H. pylori infection is planned in 5121 citizens living in different administrative districts of Moscow. The cohort will be formed based on age and sex structure of the Moscow population. The presence of H. pylori will be analyzed using 2 non-invasive methods - 13C-urease breath test and serological test (detection of IgG antibodies to H. pylori). An epidemiological questionnaire will be filled out for each respondent which will display basic information on the patient (gender, age, eating habits, bad habits, family history of cancer, etc.), as well as characterize the main symptoms, if any. Based on pepsinogen (PG) I levels and PG II (serological markers of atrophy of the gastric mucosa), patients with a high risk of atrophic gastritis and precancerous lesions in the gastric mucosa will be identified and the age and sex structure of atrophic gastritis prevalence in Moscow will be constructed.
- label
- Cohort 2
- description
- From 5121 respondents, 500 patients with confirmed H. pylori infection and serological markers of atrophic gastritis and a control group of infected with H. pylori without serological markers of gastric mucosa atrophy will be selected. They will undergo esophagogastroduodenoscopy with two gastric mucosa biopsies. The first will be conducted according to the OLGA system with a pathology assessment of the stage and degree of gastritis, while the second will be taken to determine the antimicrobial susceptibility of H. (polymerase chain reaction and culture). Correlations between serological and patholgy data on atrophy will be assessed in order to determine the reliability of serological screening for atrophy in the Moscow population.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * • Age 18 to 80 years; * Signed informed consent form. Exclusion Criteria: * Criteria for non-inclusion: * history of taking antibiotics, bismuth-containing drugs within 30 days before the visit and proton pump inhibitors within 14 days before the visit; * The presence of clinically significant neurological, cardiovascular, gastrointestinal (total of partial gastrectomy), hepatic, renal, immune and other diseases in medical history; * Patients with diagnosed cancers of any kind who require specialized treatment and/or are currently undergoing anticancer treatment; * Psychiatric illnesses, including in the past, which, in the opinion of the investigator, make the patient's participation in the study unacceptable; * Pregnancy; * Patients who tend to refuse to participate in the study and comply with doctor's recommendations; * Inability or unwillingness to give informed consent to participate in the study or to fulfill the requirements of the study; Criteria for exclusion of patients from the study 1. Refusal of further use of the drug; 2. Deterioration of objective indicators of the patient's condition;
References
Publications (12)
- RESULTMalfertheiner P, Megraud F, O'Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study Group and Consensus panel. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2017 Jan;66(1):6-30. doi: 10.1136/gutjnl-2016-312288. Epub 2016 Oct 5. PMID 27707777
- RESULTSugano K, Tack J, Kuipers EJ, Graham DY, El-Omar EM, Miura S, Haruma K, Asaka M, Uemura N, Malfertheiner P; faculty members of Kyoto Global Consensus Conference. Kyoto global consensus report on Helicobacter pylori gastritis. Gut. 2015 Sep;64(9):1353-67. doi: 10.1136/gutjnl-2015-309252. Epub 2015 Jul 17. PMID 26187502
- RESULTLiou JM, Malfertheiner P, Lee YC, Sheu BS, Sugano K, Cheng HC, Yeoh KG, Hsu PI, Goh KL, Mahachai V, Gotoda T, Chang WL, Chen MJ, Chiang TH, Chen CC, Wu CY, Leow AH, Wu JY, Wu DC, Hong TC, Lu H, Yamaoka Y, Megraud F, Chan FKL, Sung JJ, Lin JT, Graham DY, Wu MS, El-Omar EM; Asian Pacific Alliance on Helicobacter and Microbiota (APAHAM). Screening and eradication of Helicobacter pylori for gastric cancer prevention: the Taipei global consensus. Gut. 2020 Dec;69(12):2093-2112. doi: 10.1136/gutjnl-2020-322368. Epub 2020 Oct 1. PMID 33004546
- RESULTBest LM, Takwoingi Y, Siddique S, Selladurai A, Gandhi A, Low B, Yaghoobi M, Gurusamy KS. Non-invasive diagnostic tests for Helicobacter pylori infection. Cochrane Database Syst Rev. 2018 Mar 15;3(3):CD012080. doi: 10.1002/14651858.CD012080.pub2. PMID 29543326
- RESULTPimentel-Nunes P, Libanio D, Marcos-Pinto R, Areia M, Leja M, Esposito G, Garrido M, Kikuste I, Megraud F, Matysiak-Budnik T, Annibale B, Dumonceau JM, Barros R, Flejou JF, Carneiro F, van Hooft JE, Kuipers EJ, Dinis-Ribeiro M. Management of epithelial precancerous conditions and lesions in the stomach (MAPS II): European Society of Gastrointestinal Endoscopy (ESGE), European Helicobacter and Microbiota Study Group (EHMSG), European Society of Pathology (ESP), and Sociedade Portuguesa de Endoscopia Digestiva (SPED) guideline update 2019. Endoscopy. 2019 Apr;51(4):365-388. doi: 10.1055/a-0859-1883. Epub 2019 Mar 6.