Helicobacter pylori Immunology in Pediatric Patients - Study

Helicobacter pylori Immunology in Pediatric Patients - Study - HIPPY

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00040187

Enrollment

600

Registered

2026-05-12

Start date

2026-06-01

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

R10-R19

Interventions

Group 1: Outpatient cohort Patients presenting with gastrointestinal symptoms are recruited as part of routine outpatient care. Blood and stool samples are collected to determine H. pylori status and

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Presentation to pediatric gastroenterology for diagnostic evaluation with anticipated blood sampling or direct presentation for clinically indicated endoscopy - Written informed consent obtained from parent(s)/legal guardian(s) and, where applicable, assent from the participant

Exclusion criteria

Exclusion criteria: - History of gastrectomy or other relevant anatomical alterations due to prior surgical interventions - Contraindications to biopsy sampling, including ongoing therapies or coagulation disorders that preclude safe tissue collection - Children in poor general condition or with malignant or severe chronic disease associated with a life expectancy of less than 10 years

Design outcomes

Primary

Measure	Time frame
The aim of this study is the early and comprehensive characterization of Helicobacter pylori-specific T cell immune responses following initial infection. The central research question is whether CagA-specific CD8? T cell responses are associated with infection status and, in particular, with evidence of spontaneous clearance of H. pylori. To address this, (CagA-specific) CD8? T cell responses in peripheral blood and gastric tissue will be analyzed and compared across patient groups stratified by serology and direct pathogen detection into the following categories: no evidence of infection, recent infection, ongoing infection, and post-elimination status.	—

Measure

Time frame

The aim of this study is the early and comprehensive characterization of Helicobacter pylori-specific T cell immune responses following initial infection. The central research question is whether CagA-specific CD8? T cell responses are associated with infection status and, in particular, with evidence of spontaneous clearance of H. pylori. To address this, (CagA-specific) CD8? T cell responses in peripheral blood and gastric tissue will be analyzed and compared across patient groups stratified by serology and direct pathogen detection into the following categories: no evidence of infection, recent infection, ongoing infection, and post-elimination status.

—

Secondary

Measure	Time frame
Secondary objectives include assessing whether CagA-specific CD8? T cells can already be detected in the human intestine during early phases of infection and whether they are associated with local immunological alterations. In addition, exploratory analyses will investigate whether CagA-positive H. pylori infection is associated with alterations of the intestinal microbiome in pediatric patients.	—

Countries

Germany

Contacts

Public ContactMaximilian Koch

Zentrum für Kinder- und Jugendmedizin der Technische Universität München

max.koch@tum.de+49 89 3068-4000

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026