Clinical trial NCT04212585: The Status of Helicobacter Pylori Infection Among Children Visiting Assiut Children Hospital
Official title: The Status of Helicobacter Pylori Infection Among Children Visiting Assiut Children Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Helicobacter Pylori Infection
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-12-27
Enrollment: 100
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Egyptian Children aged from 0 years to 18 years old.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of H. pylori in children hospital attendees.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Magda S Hasan, M.D.
role: STUDY_DIRECTOR
References:
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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.