Skip to content

TLR 9 (rs352140) Gene Polymorphism in Helicobacter Pylori Infection

TLR 9 (rs352140) Gene Polymorphism in Helicobacter Pylori Infection in Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07289451
Enrollment
100
Registered
2025-12-17
Start date
2023-01-01
Completion date
2025-09-01
Last updated
2025-12-17

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

Conditions

H. Pylori Infection

Keywords

TLR 9

Brief summary

study aimed to identify the role of TLR9 (rs352140) gene in suppressing or promoting the inflammation related to H. pylori infection in children.This cross-sectional study was conducted on 50 children with positive H. pylori infection and 50 age and sex matched, negative H. pylori children, all children undertook full history, complete clinical investigation, laboratory testing, upper digestive endoscopies and genotyping of TLR9 (rs352140).

Detailed description

H. pylori infection is acknowledged as one of the major causes of gastrointestinal bacterial infections globally, imposing a substantial load on public health organizations, mostly in low-resource countries . H. pylori infection continues to pose a substantial challenge, particularly in vulnerable populations like infants, despite the significant advance made in health care organization and medicine . The implications of H. pylori infection in minors have a profound impact on numerous aspects of health and well-being, which extend beyond the gastrointestinal tract. In addition to its immediate effect on the gastric mucosa integrity of, H. pylori infection has systemic impacts that can have a negative impact on, growth trajectories, the nutritional status and overall health results of children who are affected . A variety of gastrointestinal disorders, involving moderate gastritis and additional serious diseases like peptic ulcer disease, have been correlated with chronic infection by H. pylori. In addition, epidemiologic evidence indicates a potential correlation between an elevated hazard for acquiring gastric adenocarcinoma and mucosa-associated lymphoid tissue lymphoma in later life and the acquisition of H. pylori infection during childhood. These long-term effects reinforce the urgent need to address H. pylori infection in children as a major community health importance . Currently, there are numerous invasive and non-invasive diagnostic assessments accessible to identify H. pylori infection in children. However, tissue culture and the rapid urease test or concordant-positive histopathology tests remains the gold standard results . Mast, macrophages, dendritic, eosinophils, neutrophils, and natural killer (NK) cells are cell actors of the innate immune system which provide antigen-independent defense against H. pylori infection . Toll-like receptors (TLRs) are critical innate immunity regulators that can be stimulated upon the identifying of pathogen-associated molecular patterns (PAMPs) such as viral and bacterial ligands. They serve as the initial line of defense for the host against a variety of circumstances, involving H. pylori infection . There are 13 TLRs (TLR1-13) in mammals, but only 10 (TLR1-10) are present in humans, but all are present in mice, with TLR10 being nonfunctional. The human stomach's gastric epithelial cells are known to produce TLR4 and TLR9, which are crucial for innate immune signaling to H. pylori .

Interventions

DIAGNOSTIC_TESTTLR TLR 9 (rs352140) gene polymorphism

Genotyping of TLR9 (rs352140) was done using TaqMan mechanism on the Applied Biosystems™ 7500Fast Dx Real-Time PCR System (Applied Biosystems, Waltham, MA, United States) and a predesigned assay, namely C\_2301954\_20. A venous blood sample (2 mls) were withdrawn from each subject and were collected into sterile ethylene diaminetetra acetate EDTA (vacutainer) tube and were used for DNA extraction. DNA was extracted from fresh samples and stored at -20 °C till time of assay for determination of TLR9 (rs352140) polymorphism by using real time Polymerase chain reaction (rt PCR) technique. The blood samples were used for DNA extraction using the Gene JET Whole Blood Genomic DNA purification Mini Kit (Thermo Fisher Scientific, Germany) according to the manufacturer's protocol. Determination of DNA concentration was done using Nanodrop One spectrophotometer (thermoscientific, USA). A concentration of (1µg) from each sample was used for genotyping by rtPCR assay. Genotyping of TLR9 (rs352140)

Sponsors

Benha University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

1. children with age between 1 and 18 years with gastrointestinal symptoms that necessitates upper digestive endoscopy like: * persistent pain in the abdomen and/or the stomach, * Heartburn, * vomiting, * nausea. 2. children who showed red flag signs like : * anemia, * gastrointestinal hemorrhage, * failure to thrive, * increased ESR .

Exclusion criteria

* cases on proton pump inhibitors, * those with substantial medical diseases, * those with gastrointestinal conditions that could explain their stomach discomfort (such as celiac disease, functional abdominal pain and inflammatory bowel disease).

Design outcomes

Primary

MeasureTime frameDescription
TLR9 rs352140 gene polymorphism correlation with of H. pylori infection and incidence of gastritis in childrenin 1 to 3 months of complaintdetermination of TLR9 (rs352140) polymorphism by using real time Polymerase chain reaction (rt PCR) technique
TLR9 rs352140 gene polymorphism with abdominal pain , H. pylori infection and incidence of gastritis in childrenin 1 -3months of symptomsdetermination of TLR9 (rs352140) polymorphism by using real time Polymerase chain reaction (rt PCR) technique

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026