H.Pylori InfectionNCT05951998
Frequency of h.Pylori in Children With Dyspeptic Symptoms
An observational study of H.Pylori Infection, run by Assiut University.
Trial summary
The current work aim to: Estimation of prevalence, Estimation of risk factors, Estimation of endoscopic picture of H. pylori infection in children presented with chronic or recurrent dyspeptic symptoms and/or non variceal hematemesis. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- H.Pylori Infection
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 1 Jun 2024
- 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 3 to 18 years
- All sexes
- Child, Adult
Study population: 100 child aged 3years to 18 years with H.pylori infection
Who may be able to join
- Children from age of 3 years to age of 18 years.
- Children presented with chronic or recurrent dyspeptic symptoms(epigastric pain, post prandial fullness, early satiety, bleaching, heart burn ,bloating ,flatulence ,regurgitation ,nausea ,vomiting and/or halitosis) and/or non variceal hematemesis.
Who cannot join
- Children less than 3 years and more than 18 years.
- Children with variceal hematemesis.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Frequency and Risk Factors of H.Pylori Infection in Children Presented by Dyspeptic Symptoms in Assiut University Children Hospital
The current work aim to:
Estimation of prevalence, Estimation of risk factors, Estimation of endoscopic picture of H. pylori infection in children presented with chronic or recurrent dyspeptic symptoms and/or non variceal hematemesis.
Read the detailed description
Helicobacter pylori infection is a common problem in pediatric practice, it's an important cause of gastrointestinal pathology in children and its acquisition is related with poor socioeconomic conditions. H.pylori is a spiral, microaerophilic, gram-negative bacterium with four to six unipolar sheathed flagella.The human stomach, especially the antrum, is the most common reservoir of this agent. American board of orthodontists antibody blood group and Lewis blood-group antigen might expose cases to H. pylori infection, the most likely mode of transmission is fecal-oral or oral-oral. H.pylori infection is predominantly acquired during early childhood .
The majority of children with are asymptomatic although a percentage of the infected children develop H. pylori associated diseases such as iron deficiency anemia, B12 deficiency, chronic thrombocytopenic purpura. It can manifest with burning pain in the stomach, nausea, loss of appetite, bloating, weight loss.
Previous studies showed that geographic area, age, race, educational level, sanitation, and socioeconomic status are among the factors that influence the prevalence of H. pylori infection . No gender differences were found in the prevalence of H. pylori infection, while it was much higher among white people.
The overall prevalence of H. pylori infection in Egyptian school children was 72.38%. There was no significant difference in the prevalence of infection between boys and girls (73.80% vs. 70.34% respectively, or in the independent effect of sex by age. Of school children living in Sohag, 96.7% tested positive for H. pylori, compared with 81.3% of children from Giza and 61.9% from Cairo. Prevalence was also highest among children of low socio-economic class and decreased gradually among children of medium to high socio-economic class.
In a previous study conducted by Hunt et al., the prevalence of H. pylori was reported to be 48% among 2-4-year-old children in Ethiopia, while in Nigeria and Mexico it was 82% and 43%, respectively, among 5-9-year-old children..
The endoscopic findings in order of decreasing frequency in the Pediatric group were nodularity (93.0%), mucosal swelling (32.6%), spotty redness (25.6%), diffuse redness (18.6%), atrophy (9.3%), enlarged fold (4.7%), depressive erosion (4.7%), foveolar-hyperplastic polyp (2.3%), patchy redness (2.3%), red streak (2.3%), and raised erosion (2.3%).
Invasive and non-invasive tests could be used for diagnosis, while the gold standard is a biopsy specimen of gastrointestinal tract.
Triple therapy is considered to be the standard treatment for children. Proton pump inhibitor combined with two antibiotics has been shown to be very effective in clearing H. pylori from the stomach, it is recommended to treat with amoxicillin, clarithromycin and a proton pump inhibitor for 2 weeks.
- Conditions
- H.Pylori Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of frequency of H.pylori infection
2.Estimation of prevalence of H.pylori infection
3.Estimation of risk factors of H.pylori infection
4.Estimation of endoscopic picture of H. pylori infection in children presented with chronic or recurrent dyspeptic symptoms and/or non variceal hematemesis.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for H.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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Samy Fayek, Assiut University
- Investigators
- Gamal A Askar, Prof, Principal investigator, Assiut UniversityAshraf M Elsaghier, Prof, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951998
- Sponsor's protocol ID
- H.pylori infection in children
- Status last verified
- Jul 2023
- First submitted
- 10 Apr 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency and Risk Factors of H.Pylori Infection in Children Presented by Dyspeptic Symptoms in Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT05951998
- Acronym / sponsor ID
- H.pylori infection in children
- Conditions
- H.Pylori Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 19 Jul 2023 (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 current work aim to:
Estimation of prevalence, Estimation of risk factors, Estimation of endoscopic picture of H. pylori infection in children presented with chronic or recurrent dyspeptic symptoms and/or non variceal hematemesis.
Detailed description
Helicobacter pylori infection is a common problem in pediatric practice, it's an important cause of gastrointestinal pathology in children and its acquisition is related with poor socioeconomic conditions. H.pylori is a spiral, microaerophilic, gram-negative bacterium with four to six unipolar sheathed flagella.The human stomach, especially the antrum, is the most common reservoir of this agent. American board of orthodontists antibody blood group and Lewis blood-group antigen might expose cases to H. pylori infection, the most likely mode of transmission is fecal-oral or oral-oral. H.pylori infection is predominantly acquired during early childhood .
The majority of children with are asymptomatic although a percentage of the infected children develop H. pylori associated diseases such as iron deficiency anemia, B12 deficiency, chronic thrombocytopenic purpura. It can manifest with burning pain in the stomach, nausea, loss of appetite, bloating, weight loss.
Previous studies showed that geographic area, age, race, educational level, sanitation, and socioeconomic status are among the factors that influence the prevalence of H. pylori infection . No gender differences were found in the prevalence of H. pylori infection, while it was much higher among white people.
The overall prevalence of H. pylori infection in Egyptian school children was 72.38%. There was no significant difference in the prevalence of infection between boys and girls (73.80% vs. 70.34% respectively, or in the independent effect of sex by age. Of school children living in Sohag, 96.7% tested positive for H. pylori, compared with 81.3% of children from Giza and 61.9% from Cairo. Prevalence was also highest among children of low socio-economic class and decreased gradually among children of medium to high socio-economic class.
In a previous study conducted by Hunt et al., the prevalence of H. pylori was reported to be 48% among 2-4-year-old children in Ethiopia, while in Nigeria and Mexico it was 82% and 43%, respectively, among 5-9-year-old children..
The endoscopic findings in order of decreasing frequency in the Pediatric group were nodularity (93.0%), mucosal swelling (32.6%), spotty redness (25.6%), diffuse redness (18.6%), atrophy (9.3%), enlarged fold (4.7%), depressive erosion (4.7%), foveolar-hyperplastic polyp (2.3%), patchy redness (2.3%), red streak (2.3%), and raised erosion (2.3%).
Invasive and non-invasive tests could be used for diagnosis, while the gold standard is a biopsy specimen of gastrointestinal tract.
Triple therapy is considered to be the standard treatment for children. Proton pump inhibitor combined with two antibiotics has been shown to be very effective in clearing H. pylori from the stomach, it is recommended to treat with amoxicillin, clarithromycin and a proton pump inhibitor for 2 weeks.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- 100 child aged 3years to 18 years with H.pylori infection
Key inclusion criteria (2 listed)
- Children from age of 3 years to age of 18 years.
- Children presented with chronic or recurrent dyspeptic symptoms(epigastric pain, post prandial fullness, early satiety, bleaching, heart burn ,bloating ,flatulence ,regurgitation ,nausea ,vomiting and/or halitosis) and/or non variceal hematemesis.
Key exclusion criteria (2 listed)
- Children less than 3 years and more than 18 years.
- Children with variceal hematemesis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Estimation of frequency of H.pylori infection
Time frame: Baseline
2.Estimation of prevalence of H.pylori infection 3.Estimation of risk factors of H.pylori infection 4.Estimation of endoscopic picture of H. pylori infection in children presented with chronic or recurrent dyspeptic symptoms and/or non variceal hematemesis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
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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.
Gamal A Askar, Prof principal investigator
Assiut University
Ashraf M Elsaghier, Prof principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of H.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 2 inclusion and 2 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 19 Jul 2023. 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 Mariam S Fayek (01277773806, romasmsmfayek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of frequency of H.pylori infection (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2023.