HELICOBACTER PYLORI INFECTIONSG-SCOGENCT07346521
Endoscopic Screening of Asymptomatic Patients for Helicobacter Pylori, Intestinal Metaplasia, and Barrett's Mucosa During Screening Colonoscopy
An observational study of HELICOBACTER PYLORI INFECTIONS and Intestinal Metaplasia, run by Sigmund Freud PrivatUniversitat at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- HELICOBACTER PYLORI INFECTIONS, Intestinal Metaplasia, Barett's Esophagus
- How many people
- 1,000 participants
- Where
- 1 siteAustria
- Study dates
- 16 Dec 2025to 16 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Asymptomatic patients without upper gastrointestinal symptoms undergoing a Screening-Colonoscopy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Wiener Privatklinik (WPK)
Vienna, 1090
Harald Rosen, Univ. Prof. Dr., +43 664 4422571, rosensurg@csi.com
About this study
Official title: Endoscopic Screening of Asymptomatic Patients for Helicobacter Pylori, Intestinal Metaplasia, and Barrett's Mucosa During Screening Colonoscopy - a Cross-sectional Study
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.
Read more
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic patients undergoing Screening-Colonoscopy | A synchronous gastroscopy performed during colonoscopy at the patient's request to detect Helicobacter pylori infection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of observation at 7 days
Secondary outcomes (1)
Asymptomatic patients who exhibit intestinal metaplasia and/or Barrett's mucosa.
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.
Measured: From enrollment to the end of observation at 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start16 Dec 2025
- Primary completion16 Dec 2026 (estimated)
- Study completion16 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HELICOBACTER PYLORI INFECTIONSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sigmund Freud PrivatUniversitat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346521
- Sponsor's protocol ID
- 17213538
- Other IDs
- 17213538
- Acronym
- G-SCOGE
- Status last verified
- Jan 2026
- First submitted
- 30 Dec 2025
- Last updated
- 9 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Due to privacy regulations and restrictions of informed consent, de-identified individual participant data will not be made available. Additional Documents: Study protocol and statistical analysis plan may be provided upon reasonable request.