Endoscopic screening for H. pylori, intestinal metaplasia, and Barrett's mucosa during screening colonoscopy
Endoscopic Screening of Asymptomatic Patients for Helicobacter Pylori, Intestinal Metaplasia, and Barrett's Mucosa During Screening Colonoscopy - a Cross-sectional Study
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 |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | Sigmund Freud PrivatUniversitat Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT07346521 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Vienna
- Wiener Privatklinik (WPK) — Vienna, Austria (Recruiting)
Study contacts
- Study coordinator: Harald Rosen, Univ. Prof. Dr.
- Email: rosensurg@csi.com
- Phone: +43 664 4422571
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.