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

NCT04212585 | Unknown

• 1 other identifier: H.Pylori status
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Helicobacter Pylori Infection

Outcome Measures

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.

  2 years

Study Arms (2)

children with upper gastrointestinal symptoms

Diagnostic Test: Serology test

children without upper gastrointestinal symptoms

Diagnostic Test: Serology test

Interventions

Serology test DIAGNOSTIC_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 with upper gastrointestinal symptoms; children without upper gastrointestinal symptoms

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Egyptian Children aged from 0 years to 18 years old.

You may qualify if:

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

You may not qualify if:

• Patients refusing to be enrolled in the study.
• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

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

  PMID: 9191731 BACKGROUND

• 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.

  PMID: 22958148 BACKGROUND

• 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.

  PMID: 17666124 BACKGROUND

• 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.

  PMID: 11982896 BACKGROUND

• 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.

  PMID: 10971680 BACKGROUND

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

  PMID: 26372825 BACKGROUND

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

  PMID: 27531540 BACKGROUND

• 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.

  PMID: 24889903 BACKGROUND

MeSH Terms

Interventions

Serologic Tests

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Magda S Hasan, M.D.

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Ebtihal R Hashem, MB

CONTACT

+201060633506; ebtihalrhs2015@gmail.com

Mohammed A Medhat Nasr, M.D.

CONTACT

+201099922736; mmedhat83@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 24, 2019
• First Posted: December 27, 2019
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: November 16, 2020

Record last verified: 2020-11