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

• Conditions: Helicobacter Pylori Infection; Child Development; Iron Deficiency Anemia

• Registration Number: NCT02654197
• Lead Sponsor: Hillel Yaffe Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-12
• Study First Submitted: 2015-12-14
• Study First Submitted QC: 2016-01-11
• Last Update Submitted: 2016-01-11
• Study First Posted: 2016-01-13
• Last Update Posted: 2016-01-13
• Study Start: 2016-06
• Primary Completion: 2019-05
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in means of differences in height	Two years	The means of the differences in height for age Z score between baseline and follow-up visits
Changes in means of differences in weight	Two years	The means of the differences in weight for age Z score between baseline and follow-up visits
Changes in means of differences in body mass index	Two years	The means of the differences in body mass index for age Z score between baseline and follow-up visits

Secondary Outcome Measures

Name	Time	Method
Changes in Iron Biomarkers	Two years	The means of the differences in iron biomarkers (hemoglobin, ferritin, iron) between baseline and follow-up visits

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel