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

November 13, 2020 updated by: Ebtihal Ramadan Hashem, Assiut University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Egyptian Children aged from 0 years to 18 years old.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
children with upper gastrointestinal symptoms
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
children without upper gastrointestinal symptoms
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of H. pylori in children hospital attendees.
Time Frame: 2 years
We need to estimate prevalence of H.Pylori infection among all children admitted in Assiut University Hospital.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Magda S Hasan, M.D., Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2021

Primary Completion (ANTICIPATED)

January 1, 2022

Study Completion (ANTICIPATED)

January 1, 2022

Study Registration Dates

First Submitted

December 24, 2019

First Submitted That Met QC Criteria

December 24, 2019

First Posted (ACTUAL)

December 27, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 16, 2020

Last Update Submitted That Met QC Criteria

November 13, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H.Pylori status

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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