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NCT Number: NCT07346521

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

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.

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Key information

Conditions

HELICOBACTER PYLORI INFECTIONS Barett's Esophagus Intestinal Metaplasia

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wiener Privatklinik (WPK)

Vienna, 1090, Austria

Location status: Recruiting

Location contact

Harald Rosen, Univ. Prof. Dr.

CONTACT

[email protected]

+43 664 4422571

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: From enrollment to the end of observation at 7 days

    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.

Secondary outcomes

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

    Time frame: From enrollment to the end of observation at 7 days

    During gastroscopy, biopsy specimens are obtained according to standard endoscopic protocols. Gastric biopsies are histopathologically processed and evaluated for the presence of intestinal metaplasia and Barrett's esophagus. Biopsies obtained from the stomach (Sydney Biopsie Protocol) the ora serrata are likewise histologically examined to identify the presence of Barrett's esophagus and/or intestinal metaplasia.The overall objective of this analysis is to assess the correlation, as well as the strength of the association, between the primary outcome, Helicobacter pylori infection, and the secondary outcomes, namely intestinal metaplasia and Barrett's mucosa.

Other outcomes

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

    Time frame: From enrollment to the end of observation at 7 days

    The primary outcome of this study is the presence of Helicobacter pylori infection. Other pre-specified outcome measures include potential risk factors such as body mass index (BMI), smoking, alcohol consumption, and family history of gastric and colorectal cancer, all evaluated in relation to Helicobacter pylori. BMI is calculated based on self-reported weight (in kilograms) and height (in meters) using the standard formula: BMI = weight / (height²). Alcohol consumption and smoking habits are recorded through participant self-report, as is family history, which is assessed by asking whether there is a documented occurrence of gastric or colorectal cancer in first-degree relatives. These measures allow the analysis of correlations between Helicobacter pylori infection and established risk factors

Study contacts

Contact information is provided by the study sponsor or research team.

Harald Rosen, Univ. Prof. Dr.

CONTACT

[email protected]

+43 664 4422571

Sponsors and collaborators

Lead sponsor

Sigmund Freud PrivatUniversitat

Other

Registry information

Official study title

Endoscopic Screening of Asymptomatic Patients for Helicobacter Pylori, Intestinal Metaplasia, and Barrett's Mucosa During Screening Colonoscopy - a Cross-sectional Study

Acronym: G-SCOGE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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