Distribution Characteristics of Helicobacter Pylori

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 18 to 80 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: Cases that underwent gastric H. pylori immunohistochemical staining at our center from March 1, 2023, to August 15, 2025.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Distribution Characteristics of Helicobacter Pylori in Different Gastritis and Early Gastric Cancer States Using Immunohistochemical Staining

Conditions

Helicobacter Pylori, Early Gastric Cancer

Being tested

immunohistochemical testing

Keywords

Helicobacter pylori, Immunohistochemical staining, Atrophic gastritis, Early gastric cancer screening

Medical subject headings

Stomach Neoplasms, Gastritis, Atrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• immunohistochemical testingDiagnostic test

  Immunohistochemical results were reviewed independently by two experienced pathologists, with disagreements resolved by a third. Immunohistochemical staining was performed using an anti-H. pylori antibody (Beijing Zhongshan Golden Bridge Biotechnology Co., Ltd, Beijing, China). Positive results were graded as mild (1+): occasional bacteria or colonization in <1/3 of the specimen length; moderate (2+): colonization exceeding 1/3 but <2/3 of the specimen, or continuous but sparse distribution on the epithelial surface; and severe (3+): clusters of H. pylori distributed across the full length of the specimen. The gastric body and antrum were assessed separately, and distribution patterns were classified as gastric antrum > gastric body, gastric antrum = gastric body, or gastric body > gastric antrum. The distribution of H. pylori across subgroups was compared, and multivariate analyses were performed to identify risk factors associated with the development of early gastric cancer.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. The status of Helicobacter pylori(H. pylori)

   The status of H. pylori included negative and positive status. Positve results were graded as mild (1+): occasional bacteria or colonization in <1/3 of the specimen length; moderate (2+): colonization exceeding 1/3 but <2/3 of the specimen, or continuous but sparse distribution on the epithelial surface; and severe (3+): clusters of H. pylori distributed across the full length of the specimen. The gastric body and antrum were assessed separately.

   Measured: one week after the endoscopic submucosal dissection (ESD)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted28 Nov 2025
2. Study start22 Oct 2025
3. Primary completion31 Dec 2025 (estimated)
4. Study completion31 Dec 2025 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Helicobacter PyloriStudies 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.