Helicobacter Pylori InfectionNCT04212585
The Status of Helicobacter Pylori Infection Among Children Visiting Assiut Children Hospital
An observational study of Helicobacter Pylori Infection, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Serology test
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Egyptian Children aged from 0 years to 18 years old.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Serology test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serology testDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| children with upper gastrointestinal symptoms | Not described Receives: Diagnostic Test: Serology test | |
| children without upper gastrointestinal symptoms | Not described Receives: Diagnostic Test: Serology test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2019
- Study start1 Jan 2021 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebtihal Ramadan Hashem, Assiut University
- Investigators
- Magda S Hasan, M.D., Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212585
- Sponsor's protocol ID
- H.Pylori status
- Status last verified
- Nov 2020
- First submitted
- 24 Dec 2019
- Last updated
- 16 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Blecker U. Helicobacter pylori-associated gastroduodenal disease in childhood. South Med J. 1997 Jun;90(6):570-6; quiz 577.
PubMed 9191731Tonkic 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 22958148Mohammad 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 17666124Takahashi 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 11982896Malaty 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 10971680Roma E, Miele E. Helicobacter pylori Infection in Pediatrics. Helicobacter. 2015 Sep;20 Suppl 1:47-53. doi: 10.1111/hel.12257.
PubMed 26372825Sustmann A, Okuda M, Koletzko S. Helicobacter pylori in children. Helicobacter. 2016 Sep;21 Suppl 1:49-54. doi: 10.1111/hel.12341.
PubMed 27531540Plummer 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Status of Helicobacter Pylori Infection Among Children Visiting Assiut Children Hospital
- ClinicalTrials.gov ID
- NCT04212585
- Acronym / sponsor ID
- H.Pylori status
- Conditions
- Helicobacter Pylori Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 27 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children with upper gastrointestinal symptoms | – | Diagnostic Test: Serology test |
| children without upper gastrointestinal symptoms | – | Diagnostic Test: Serology test |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Egyptian Children aged from 0 years to 18 years old.
Key inclusion criteria (5 listed)
- All children (<18 years) attending healthcare facilities for any reason will be enrolled after informed consent of their parents to participate in the study.
- 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.
Key exclusion criteria (6 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serology testSerology 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 | Diagnostic test | children with upper gastrointestinal symptoms, children without upper gastrointestinal symptoms |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Background: PubMed 9191731Blecker U. Helicobacter pylori-associated gastroduodenal disease in childhood. South Med J. 1997 Jun;90(6):570-6; quiz 577.
- Background: PubMed 22958148Tonkic 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.
- Background: PubMed 17666124Mohammad 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.
- Background: PubMed 11982896Takahashi 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.
- Background: PubMed 10971680Malaty 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.
- Background: PubMed 26372825Roma E, Miele E. Helicobacter pylori Infection in Pediatrics. Helicobacter. 2015 Sep;20 Suppl 1:47-53. doi: 10.1111/hel.12257.
- Background: PubMed 27531540Sustmann A, Okuda M, Koletzko S. Helicobacter pylori in children. Helicobacter. 2016 Sep;21 Suppl 1:49-54. doi: 10.1111/hel.12341.
- Background: PubMed 24889903Plummer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magda S Hasan, M.D. study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Infection, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ebtihal R Hashem, MB (+201060633506, ebtihalrhs2015@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of H. pylori in children hospital attendees. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04212585, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2020.