TLR 9 (rs352140) Gene Polymorphism in Helicobacter Pylori Infection

NCT07289451 | Completed DMC

• 1 other identifier: MS-14-12-2022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

H. Pylori Infection

Keywords

TLR 9

Outcome Measures

Primary Outcomes (2)

• TLR9 rs352140 gene polymorphism correlation with of H. pylori infection and incidence of gastritis in children

  determination of TLR9 (rs352140) polymorphism by using real time Polymerase chain reaction (rt PCR) technique

  in 1 to 3 months of complaint

• TLR9 rs352140 gene polymorphism with abdominal pain , H. pylori infection and incidence of gastritis in children

  determination of TLR9 (rs352140) polymorphism by using real time Polymerase chain reaction (rt PCR) technique

  in 1 -3months of symptoms

Study Arms (1)

children with age between 1 and 18 years with gastrointestinal symptoms that necessitates upper dige

EXPERIMENTAL

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, and nausea. Additionally, children who showed red flag signs like anemia, gastrointestinal hemorrhage, failure to thrive, or increased ESR were as well involved.

Diagnostic Test: TLR TLR 9 (rs352140) gene polymorphism

Interventions

TLR TLR 9 (rs352140) gene polymorphism DIAGNOSTIC_TEST

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 A venous blood sample (2 mls) were withdrawn from each subject and were collected into sterile ethylene diaminetetra acetate "EDTA" (vacutainer) tube and were used for DNA extraction.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)

children with age between 1 and 18 years with gastrointestinal symptoms that necessitates upper dige

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• children who showed red flag signs like :
• anemia,
• gastrointestinal hemorrhage,
• failure to thrive,
• increased ESR .

You may not qualify if:

• 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).

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Faculty of Medicine Benha University

Cairo, Egypt

Location

Related Publications (3)

• Wicherska-Pawlowska K, Wrobel T, Rybka J. Toll-Like Receptors (TLRs), NOD-Like Receptors (NLRs), and RIG-I-Like Receptors (RLRs) in Innate Immunity. TLRs, NLRs, and RLRs Ligands as Immunotherapeutic Agents for Hematopoietic Diseases. Int J Mol Sci. 2021 Dec 13;22(24):13397. doi: 10.3390/ijms222413397.

  PMID: 34948194 RESULT

• Elbehiry A, Marzouk E, Aldubaib M, Abalkhail A, Anagreyyah S, Anajirih N, Almuzaini AM, Rawway M, Alfadhel A, Draz A, Abu-Okail A. Helicobacter pylori Infection: Current Status and Future Prospects on Diagnostic, Therapeutic and Control Challenges. Antibiotics (Basel). 2023 Jan 17;12(2):191. doi: 10.3390/antibiotics12020191.

  PMID: 36830102 RESULT

• Nguyen J, Kotilea K, Bontems P, Miendje Deyi VY. Helicobacter pylori Infections in Children. Antibiotics (Basel). 2023 Sep 12;12(9):1440. doi: 10.3390/antibiotics12091440.

  PMID: 37760736 RESULT

MeSH Terms

Interventions

Polymorphism, Genetic

Intervention Hierarchy (Ancestors)

Genetic Variation; Genetic Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of pediatrics

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 17, 2025
• Study Start: January 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)