Potential Adverse Developmental and Nutritional Consequences of Helicobacter Pylori Infection in Israeli Children

Study Overview
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Brief Summary
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The investigators believe that there is an association between H. pylori infection and nutritional status and between H. pylori infection and cognitive development. The current study will examine this association in Israeli children, aged 6-12 years.

Official Title
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Potential Adverse Developmental and Nutritional Consequences of Helicobacter Pylori Infection in Israeli Children

Conditions
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Helicobacter Pylori Infection, Iron Deficiency Anemia, Child Development

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent by parents/guardians and children Exclusion Criteria: Growth retardation history History of prior therapy for H. pylori irradiation Hematological disorders Developmental delays

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| H.pylori positive children<br>Healthy children, 6-12 years old, will undergo screening for H. pylori infection by measuring anti-H. pylori and CagA IgG antibodies in the serum. The status of H. pylori infection will be confirmed using breath test (UBT). Children will be classified as i) H. pylori negative, if they test negative on UBT ii) H. pylori positive- CagA negative, if they test positive on UBT, but lack serum CagA IgG antibodies iii) H. pylori positive- CagA positive, if they are positive for H. pylori on UBT and CagA IgG antibodies. | |
| H.Pylori negative children<br>Healthy children, 6-12 years old, will undergo screening for H. pylori infection by measuring anti-H. pylori and CagA IgG antibodies in the serum. The status of H. pylori infection will be confirmed using breath test (UBT). Children will be classified as i) H. pylori negative, if they test negative on UBT ii) H. pylori positive- CagA negative, if they test positive on UBT, but lack serum CagA IgG antibodies iii) H. pylori positive- CagA positive, if they are positive for H. pylori on UBT and CagA IgG antibodies. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in means of differences in height | The means of the differences in height for age Z score between baseline and follow-up visits | Two years | 
| Changes in means of differences in weight | The means of the differences in weight for age Z score between baseline and follow-up visits | Two years | 
| Changes in means of differences in body mass index | The means of the differences in body mass index for age Z score between baseline and follow-up visits | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Iron Biomarkers | The means of the differences in iron biomarkers (hemoglobin, ferritin, iron) between baseline and follow-up visits | Two years |