Endoscopic Screening of Asymptomatic Patients for Helicobacter Pylori, Intestinal Metaplasia, and Barrett's Mucosa During Screening Colonoscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: HELICOBACTER PYLORI INFECTIONS, Intestinal Metaplasia, Barett's Esophagus. Basic parameters: from 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Endoscopic Screening of Asymptomatic Patients for Helicobacter Pylori, Intestinal Metaplasia, and Barrett's Mucosa During Screening Colonoscopy - a Cross-sectional Study
Overview
The goal of this observational study is to learn how common Helicobacter pylori (H. pylori) infection is in adults without stomach or upper gastrointestinal symptoms who are having a preventive screening colonoscopy. Endoscopic screening of the stomach is yet not acceptet as a standard screening procedure in Western countries. However, Helicobacter pylori infection is known to increase the risk of developing gastric cancer. This study will look at the prevalence of Helicobacter pylori infection in asymptomatic patients who have an additional gastroscopy during the same session as their screening colonoscopy. It will also record other early tissue changes or risk factors for stomach cancer, such as intestinal metaplasia and Barrett's mucosa. The main questions this study aims to answer are: * How often is Helicobacter pylori found in adults without upper gastrointestinal symptoms by use of OGD? * Are there any correlations between H. pylori infection and other risk factors, such as BMI, smoking, alcohol consumption, or a family history of colorectal and/or stomach cancer? About 1000 participants are expected to take part. Adults undergoing a screening colonoscopy at a private endoscopy center will be offered the chance to have an additional gastroscopy if they meet the study's inclusion criteria (no previous Helicobacter pylori infection and no upper gastrointestinal symptoms). Small tissue samples (biopsies) will be taken from the stomach and lower esophagus during the gastroscopy. Biopsies will be checked histologically for the presence of Helicobacter pylori and early tissue changes. During the gastroscopy, no additional procedures or biopsies will be done beyond what is normally performed during a routine examination. Everything done during this procedure follows the standard steps of a regular gastroscopy. All data will be coded to protect participant privacy. Researchers will use statistical methods to find out how common Helicobacter pylori infection is and whether it is related to other lifestyle or family risk factors or tissue changes.
Primary outcome measures
- The number of asymptomatic patients who are Helicobacter-positive. [Time frame: From enrollment to the end of observation at 7 days]
Secondary outcome measures (1)
- Asymptomatic patients who exhibit intestinal metaplasia and/or Barrett's mucosa. [Time frame: From enrollment to the end of observation at 7 days]
Eligibility criteria
Inclusion criteria
- Age ≥ 30 years
- Scheduled screening colonoscopy (either initial screening or surveillance following previously detected polyps)
- Asymptomatic (no gastrointestinal symptoms)
- Willingness and consent to undergo simultaneous gastroscopy with biopsy sampling
- Written informed consent to participate in the study, including the use of histological findings and patient data for study analysis
Exclusion criteria
- Known Helicobacter pylori infection or previous treatment for H. pylori
- Current or recent proton pump inhibitor (PPI) therapy (< 4 weeks)
- Pre-existing gastrointestinal diseases (e.g., chronic gastritis, ulcer, gastric carcinoma)
- Immunosuppression or relevant underlying diseases
- Refusal to undergo additional gastroscopy or biopsy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Austria · 1 center
- Wiener Privatklinik (WPK) — Vienna
Identifiers
NCT: NCT07346521 · 17213538 · 17213538