HELICOBACTER PYLORI INFECTIONSNCT06938035
Effect of H.Pylori Infection on Growth Parameters
An observational study of HELICOBACTER PYLORI INFECTIONS, run by Assiut University.
Trial summary
This study aimed to assess the effect H.pylori infection on growth parameter Of primary school-aged children Attending Assuit university chilren hospital Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- HELICOBACTER PYLORI INFECTIONS
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 13 May 2025to 31 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- Child
Study population: primary school-aged children Attending Assuit university hospital Of pediatrics .
Who may be able to join
- Primary school children aged 6 to 12 years old.
- Children who have tested positive for Helicobacter pylori.
Who cannot join
- Children with primary malnutrition due to nutritional deficiency .
- Children with chronic illness
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of H.Pylori Infection on Growth Parameters Of Primary School-aged Children Attending Assuit University Children Hospital
This study aimed to assess the effect H.pylori infection on growth parameter Of primary school-aged children Attending Assuit university chilren hospital
Read the detailed description
Undernutrition is caused by insufficient intake, malabsorption, inadequate utilization, and increased demand. There is a positive association between undernutrition and various infections. Chronic exposure to pathogens may affect nutrient absorption and increase nutrient consumption, Among many potential pathogens, chronic Helicobacter pylori (H. pylori) infection may be one cause of undernutrition. H. pylori is a gram-negative, helical, and microaerophilic bacterium, which colonizes gastric epithelial cells' surface. The mode of transmission of H. pylori is not known exactly, but the faecal-oral or oral-oral routes via water or food consumption are thought to be a very common cause. The frequency of H.pylori infection increases with age. The rate of development is higher in societies with low socioeconomic status .
The worldwide prevalence of H. pylori in children varies significantly, from 2.5% in Japan to 34.6% in Ethiopia. Gastric mucosal host factors, as well as environmental and virulence factors of the bacteria, are associated with the clinical outcome of H. pylori infection. it is closely related to chronic gastritis, dyspepsia, and chronic diarrhea. H pylori also remains an important risk factor for duodenal ulcers and duodenal and gastric erosions in children.A number of studies identified correlations of H pylori infection in children with a variety of gastrointestinal diseases including autoimmune gastritis and celiac disease. It also produces different biological effects on hormones such as ghrelin and leptin, which control both growth and appetite, causing changes in appetite and food intake, while causing changes in immunological symptoms and responses .H. pylori is a factor that causes malnutrition and growth retardation, due to malabsorption of nutrients and increased susceptibility to enteric infections, especially in developing countries .
- Conditions
- HELICOBACTER PYLORI INFECTIONS
What is being measured
The primary outcome is the main question the study is designed to answer.
H.pylori infection and its effect on growth parameter
Assess the effect of H.pylori infection on growth parameter of primary school-aged children attending Assiut university children hospital by assesing :
- anthropometric measurement :Weigt (kg), height(cm) ,head circumference (cm),body mass index(m2/kg)
- cbc
- serum albumin
- stool analysis
- upper endoscopy
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start13 May 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HELICOBACTER PYLORI INFECTIONSStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed shaban Abdelqway Gomaa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938035
- Sponsor's protocol ID
- H.pylori infection
- Status last verified
- Apr 2025
- First submitted
- 2 Oct 2024
- Last updated
- 22 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zamani M, Vahedi A, Maghdouri Z, Shokri-Shirvani J. Role of food in environmental transmission of Helicobacter pylori. Caspian J Intern Med. 2017 Summer;8(3):146-152. doi: 10.22088/cjim.8.3.146.
PubMed 28932364Hooi JKY, Lai WY, Ng WK, Suen MMY, Underwood FE, Tanyingoh D, Malfertheiner P, Graham DY, Wong VWS, Wu JCY, Chan FKL, Sung JJY, Kaplan GG, Ng SC. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology. 2017 Aug;153(2):420-429. doi: 10.1053/j.gastro.2017.04.022. Epub 2017 Apr 27.
PubMed 28456631
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of H.Pylori Infection on Growth Parameters Of Primary School-aged Children Attending Assuit University Children Hospital
- ClinicalTrials.gov ID
- NCT06938035
- Acronym / sponsor ID
- H.pylori infection
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 13 May 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 22 Apr 2025 (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.
This study aimed to assess the effect H.pylori infection on growth parameter Of primary school-aged children Attending Assuit university chilren hospital
Detailed description
Undernutrition is caused by insufficient intake, malabsorption, inadequate utilization, and increased demand. There is a positive association between undernutrition and various infections. Chronic exposure to pathogens may affect nutrient absorption and increase nutrient consumption, Among many potential pathogens, chronic Helicobacter pylori (H. pylori) infection may be one cause of undernutrition. H. pylori is a gram-negative, helical, and microaerophilic bacterium, which colonizes gastric epithelial cells' surface. The mode of transmission of H. pylori is not known exactly, but the faecal-oral or oral-oral routes via water or food consumption are thought to be a very common cause. The frequency of H.pylori infection increases with age. The rate of development is higher in societies with low socioeconomic status .
The worldwide prevalence of H. pylori in children varies significantly, from 2.5% in Japan to 34.6% in Ethiopia. Gastric mucosal host factors, as well as environmental and virulence factors of the bacteria, are associated with the clinical outcome of H. pylori infection. it is closely related to chronic gastritis, dyspepsia, and chronic diarrhea. H pylori also remains an important risk factor for duodenal ulcers and duodenal and gastric erosions in children.A number of studies identified correlations of H pylori infection in children with a variety of gastrointestinal diseases including autoimmune gastritis and celiac disease. It also produces different biological effects on hormones such as ghrelin and leptin, which control both growth and appetite, causing changes in appetite and food intake, while causing changes in immunological symptoms and responses .H. pylori is a factor that causes malnutrition and growth retardation, due to malabsorption of nutrients and increased susceptibility to enteric infections, especially in developing countries .
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- primary school-aged children Attending Assuit university hospital Of pediatrics .
Key inclusion criteria (2 listed)
- Primary school children aged 6 to 12 years old.
- Children who have tested positive for Helicobacter pylori.
Key exclusion criteria (2 listed)
- Children with primary malnutrition due to nutritional deficiency .
- Children with chronic illness
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
H.pylori infection and its effect on growth parameter
Time frame: baseline
Assess the effect of H.pylori infection on growth parameter of primary school-aged children attending Assiut university children hospital by assesing : 1. anthropometric measurement :Weigt (kg), height(cm) ,head circumference (cm),body mass index(m2/kg) 2. cbc 3. serum albumin 4. stool analysis 5. upper endoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Results publication: PubMed 28932364Zamani M, Vahedi A, Maghdouri Z, Shokri-Shirvani J. Role of food in environmental transmission of Helicobacter pylori. Caspian J Intern Med. 2017 Summer;8(3):146-152. doi: 10.22088/cjim.8.3.146.
- Results publication: PubMed 28456631Hooi JKY, Lai WY, Ng WK, Suen MMY, Underwood FE, Tanyingoh D, Malfertheiner P, Graham DY, Wong VWS, Wu JCY, Chan FKL, Sung JJY, Kaplan GG, Ng SC. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology. 2017 Aug;153(2):420-429. doi: 10.1053/j.gastro.2017.04.022. Epub 2017 Apr 27.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of HELICOBACTER PYLORI INFECTIONS, 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: opening soon, as of the sponsor's last update on 22 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Shaban Abdelqway, Bachelor of Medicine (01099847969, mohamedmody555888@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H.pylori infection and its effect on growth parameter (time frame: baseline). 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 NCT06938035, which also lists 2 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 22 Apr 2025.