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Status unknownNCT04212585Updated Nov 16, 2020

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

An observational study in Helicobacter Pylori Infection, sponsored by Assiut University. Status unknown. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2020-11-16.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
100
Ages
Up to 18 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

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In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 100 is below the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Egyptian Children aged from 0 years to 18 years old.

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

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.
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • children with upper gastrointestinal symptoms

    Diagnostic Test: Serology test

  • children without upper gastrointestinal symptoms

    Diagnostic Test: Serology test

Interventions

  • Diagnostic testSerology 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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 years

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Blecker U. Helicobacter pylori-associated gastroduodenal disease in childhood. South Med J. 1997 Jun;90(6):570-6; quiz 577. PubMed 9191731 ↗
  • Tonkic A, Tonkic M, Lehours P, Megraud 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. PubMed 22958148 ↗
  • 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. doi: 10.1017/S1368980007000481. Epub 2007 Aug 1. PubMed 17666124 ↗
  • Takahashi M, Kimura H, Watanabe K. Helicobacter pylori infection in patients with idiopathic short stature. Pediatr Int. 2002 Jun;44(3):277-80. doi: 10.1046/j.1442-200x.2002.01557.x. PubMed 11982896 ↗
  • 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. doi: 10.1046/j.1523-5378.2000.00024.x. PubMed 10971680 ↗
  • Roma E, Miele E. Helicobacter pylori Infection in Pediatrics. Helicobacter. 2015 Sep;20 Suppl 1:47-53. doi: 10.1111/hel.12257. PubMed 26372825 ↗
  • Sustmann A, Okuda M, Koletzko S. Helicobacter pylori in children. Helicobacter. 2016 Sep;21 Suppl 1:49-54. doi: 10.1111/hel.12341. PubMed 27531540 ↗
  • 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. PubMed 24889903 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04212585
Lead sponsor
Assiut University
Responsible party
Ebtihal Ramadan Hashem (Principal Investigator, Assiut University) — Principal investigator
First posted
Dec 27, 2019
Start date
Jan 1, 2021 (estimated)
Primary completion
Jan 1, 2022 (estimated)
Completion
Jan 1, 2022 (estimated)
Last update
Nov 16, 2020

Study contacts

Ebtihal R Hashem, MB
Contact
ebtihalrhs2015@gmail.com
+201060633506
Mohammed A Medhat Nasr, M.D.
Contact
mmedhat83@gmail.com
+201099922736
Magda S Hasan, M.D.
study director · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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