Endoscopic Screening of Asymptomatic Patients for Helicobacter Pylori, Intestinal Metaplasia, and Barrett's Mucosa During Screening Colonoscopy

NCT07346521 | Recruiting

• 1 other identifier: 17213538
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

HELICOBACTER PYLORI INFECTIONS; Intestinal Metaplasia; Barett's Esophagus

Outcome Measures

Primary Outcomes (1)

• The number of asymptomatic patients who are Helicobacter-positive.

  All study participants undergo upper gastrointestinal endoscopy (gastroscopy). During the procedure, gastric biopsy specimens are obtained and subsequently processed for histopathological evaluation. The biopsies are analyzed to determine the presence of Helicobacter pylori infection. For statistical analysis, Helicobacter pylori status is coded as follows: absence of infection is recorded as 0, mild infection as 1, moderate infection as 2, and severe infection as 3.

  From enrollment to the end of observation at 7 days

Secondary Outcomes (1)

• Asymptomatic patients who exhibit intestinal metaplasia and/or Barrett's mucosa.

  From enrollment to the end of observation at 7 days

Other Outcomes (1)

• Association of BMI, smoking, alcohol consumption, and family history with gastric- and colorectal cancer in relation to Helicobacter pylori infection

  From enrollment to the end of observation at 7 days

Study Arms (1)

Asymptomatic patients undergoing Screening-Colonoscopy

A synchronous gastroscopy performed during colonoscopy at the patient's request to detect Helicobacter pylori infection.

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Asymptomatic patients without upper gastrointestinal symptoms undergoing a Screening-Colonoscopy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sigmund Freud PrivatUniversitat: lead

Study Sites (1)

Wiener Privatklinik (WPK)

Vienna, 1090, Austria

RECRUITING

Central Study Contacts

Harald Rosen, Univ. Prof. Dr.

CONTACT

+43 664 4422571; rosensurg@csi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 16, 2026
• Study Start: December 16, 2025
• Primary Completion (Estimated): December 16, 2026
• Study Completion (Estimated): December 16, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: December 2025- December 2026 (12 months)

Locations

AU (1)