The Status of Helicobacter Pylori Infection Among Children Visiting Assiut Children Hospital

Helicobacter Pylori Infection Clinical Trial

Official title:

The Status of Helicobacter Pylori Infection Among Children Visiting Assiut Children Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04212585
• Other study ID #: H.Pylori status
• Status: Not yet recruiting
• Start date: January 1, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: November 2020
• Source: Assiut University
• Contact: Ebtihal R Hashem, MB
• Phone: +201060633506
• Email: ebtihalrhs2015[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to estimate the prevalence of Helicobacter pylori infection among Egyptian children attending to healthcare facilitates using different diagnostic tools.

Description:

The prevalence of H. pylori infection, which has a ubiquitous distribution, varies depending on socioeco- nomic factors and age. in the context of a decreased trend in H. pylori prevalence, at least 50% of the world's hu-man population are carriers of the microorganism, with a prevalence much higher in developing countries than in developed countries. H. pylori infection was evaluated in 286 Egyptian school children, and the overall prevalence was > 72%. Acquisition of the infection occurs mostly in early childhood; therefore, a better understanding of the epidemiology and the risk factors associated with H. pylori infection in the pediatric population is important to clarify the natural history and complications of the infection and programming eradication strategies.

Currently, little data exist regarding the epidemiology of H. pylori associated infection in our region., especially in children. Therefore, this study aims to determine the prevalence of H. pylori among children.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• All children (<18 years) attending healthcare facilities for any reason will be enrolled after informed consent of their parents to participate in the study.

Participants will be recruited from the following sources:

1. Children with non-GI symptoms (ophthalmology, ear, nose, and throat , chest departments .. etc)

2. Children with GI symptoms undergoing upper GI endoscopy (from GI endoscopy units).

Simple questionnaire will be used to collect demographic data, socioeconomic status, dietary habits, and gastrointestinal complaints from parents of all participants before testing for Helicobacter pylori.

Exclusion Criteria:

1. Patients refusing to be enrolled in the study.

2. For any diagnostic test other than serology (stool antigen, rapid Urease test, urea breath test, histopathology) the following patients will be excluded:

• Children received any antibiotics in the last month

• Children received bismuth compounds in the last month.

• Children received proton pump inhibitors in the last 2 weeks.

• Children presenting with upper gastrointestinal bleeding.

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection

Intervention

Diagnostic Test:
• Serology test
Serology for Helicobacter pylori (immunoglobulin G for all sites, immunoglobulin M optional, immunoglobulin A optional) will be collected from all participants. 90 samples (immunoglobulin G, immunoglobulin M and immunoglobulin A) at least needed from each site. Stool antigen for Helicobacter pylori

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (8)

Blecker U. Helicobacter pylori-associated gastroduodenal disease in childhood. South Med J. 1997 Jun;90(6):570-6; quiz 577. Review. — View Citation

Malaty HM, Logan ND, Graham DY, Ramchatesingh JE, Reddy SG. Helicobacter pylori infection in asymptomatic children: comparison of diagnostic tests. Helicobacter. 2000 Sep;5(3):155-9. — View Citation

Mohammad MA, Hussein L, Coward A, Jackson SJ. Prevalence of Helicobacter pylori infection among Egyptian children: impact of social background and effect on growth. Public Health Nutr. 2008 Mar;11(3):230-6. Epub 2007 Aug 1. — View Citation

Plummer M, Franceschi S, Vignat J, Forman D, de Martel C. Global burden of gastric cancer attributable to Helicobacter pylori. Int J Cancer. 2015 Jan 15;136(2):487-90. doi: 10.1002/ijc.28999. Epub 2014 Jun 11. — View Citation

Roma E, Miele E. Helicobacter pylori Infection in Pediatrics. Helicobacter. 2015 Sep;20 Suppl 1:47-53. doi: 10.1111/hel.12257. Review. — View Citation

Sustmann A, Okuda M, Koletzko S. Helicobacter pylori in children. Helicobacter. 2016 Sep;21 Suppl 1:49-54. doi: 10.1111/hel.12341. Review. — View Citation

Takahashi M, Kimura H, Watanabe K. Helicobacter pylori infection in patients with idiopathic short stature. Pediatr Int. 2002 Jun;44(3):277-80. — View Citation

Tonkic A, Tonkic M, Lehours P, Mégraud F. Epidemiology and diagnosis of Helicobacter pylori infection. Helicobacter. 2012 Sep;17 Suppl 1:1-8. doi: 10.1111/j.1523-5378.2012.00975.x. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of H. pylori in children hospital attendees.	We need to estimate prevalence of H.Pylori infection among all children admitted in Assiut University Hospital.	2 years