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NCT02654197 Clinical Trial

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

Helicobacter Pylori Infection Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02654197
Other study ID # HYMC-0093-15
Secondary ID
Status Not yet recruiting
Phase N/A
First received December 14, 2015
Last updated January 11, 2016
Start date June 2016
Est. completion date May 2019

Study information
Verified date December 2015
Source Hillel Yaffe Medical Center
Contact Amit Hochberg, MD
Phone 972-4-6304320
Email amit.hochberg@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 600
Est. completion date May 2019
Est. primary completion date May 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Years to 12 Years
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Other Changes in Intelligence quotient (IQ) scores Changes in full-Scale IQ scores and-sub-scores on WISC test between baseline and 24-months follow-up visit: will be defined as the means of the differences of these scores. Two years No
Primary 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 No
Primary 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 No
Primary 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 No
Secondary Changes in Iron Biomarkers The means of the differences in iron biomarkers (hemoglobin, ferritin, iron) between baseline and follow-up visits Two years No
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