NCT07346521 Endoscopic Screening of Asymptomatic Patients for Helicobacter Pylori, Intestinal Metaplasia, and Barrett's Mucosa During Screening Colonoscopy
| NCT ID | NCT07346521 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sigmund Freud PrivatUniversitat |
| Condition | HELICOBACTER PYLORI INFECTIONS |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-12-16 |
| Primary Completion | 2026-12-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2025-12-16 with a primary completion date of 2026-12-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07346521 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, studying HELICOBACTER PYLORI INFECTIONS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07346521 currently recruiting?
Yes, NCT07346521 is actively recruiting participants. Contact the research team at rosensurg@csi.com for enrollment information.
Where is the NCT07346521 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT07346521 clinical trial?
NCT07346521 is sponsored by Sigmund Freud PrivatUniversitat. The trial plans to enroll 1,000 participants.