Endoscopic screening for H. pylori, intestinal metaplasia, and Barrett's mucosa during screening colonoscopy
Official title: Endoscopic Screening of Asymptomatic Patients for Helicobacter Pylori, Intestinal Metaplasia, and Barrett's Mucosa During Screening Colonoscopy - a Cross-sectional Study
Run by Sigmund Freud PrivatUniversitat · NCT07346521 · Data updated 2026-11-12
This project will try adding a gastroscopy with biopsies to routine screening colonoscopy to see how often H. pylori and early stomach changes appear in adults without upper GI symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 30 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Sigmund Freud PrivatUniversitat Academic / other |
| Locations | 1 site (Vienna) |
| Status | Recruiting |
| Started | December 16, 2025 |
| Main results expected | December 16, 2026 |
| Study ends | December 16, 2026 |
| Registry record updated | March 9, 2026 |
| Trial ID | NCT07346521 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 30 or older scheduled for screening or surveillance colonoscopy who have no upper GI symptoms and are willing to undergo an additional gastroscopy with biopsies are ideal candidates.
✕Probably not a fit
People with known prior H. pylori infection or treatment, recent proton pump inhibitor use, active gastrointestinal disease, significant immunosuppression, or those who refuse gastroscopy or biopsy are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational study enrolling adults aged 30 and older who are scheduled for screening or surveillance colonoscopy and do not have upper gastrointestinal symptoms. Participants who consent will undergo a simultaneous gastroscopy (OGD) with biopsy sampling to test for H. pylori and to document intestinal metaplasia and Barrett's mucosa. The study will record the prevalence of H. pylori and correlate infection status with other histologic findings and clinical risk factors. Patients with prior H. pylori treatment, recent PPI use, or pre-existing GI disease are excluded.
Why it matters
Potential benefit: If common, detecting unnoticed H. pylori infection or early precancerous changes during routine colonoscopy could allow earlier treatment or surveillance to reduce stomach cancer risk.
How similar studies have gone: Previous prevalence studies have found H. pylori and precancerous gastric changes in asymptomatic populations, but routine simultaneous gastroscopy during screening colonoscopy is not widely practiced and remains relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Wiener Privatklinik (WPK)
Vienna, Austria Recruiting
Study contacts
- Study coordinator: Harald Rosen, Univ. Prof. Dr.
- Email: rosensurg@csi.com
- Phone: +43 664 4422571
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.