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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02654197
Enrollment
600
Registered
2016-01-13
Start date
2016-06-30
Completion date
2019-05-31
Last updated
2016-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Development, Helicobacter Pylori Infection, Iron Deficiency Anemia

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.

Interventions

None listed

Sponsors

Hillel Yaffe Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in means of differences in heightTwo yearsThe means of the differences in height for age Z score between baseline and follow-up visits
Changes in means of differences in weightTwo yearsThe means of the differences in weight for age Z score between baseline and follow-up visits
Changes in means of differences in body mass indexTwo yearsThe means of the differences in body mass index for age Z score between baseline and follow-up visits

Secondary

MeasureTime frameDescription
Changes in Iron BiomarkersTwo yearsThe means of the differences in iron biomarkers (hemoglobin, ferritin, iron) between baseline and follow-up visits

Other

MeasureTime frameDescription
Changes in Intelligence quotient (IQ) scoresTwo yearsChanges 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.

Countries

Israel

Contacts

Primary ContactAmit Hochberg, MD
amit.hochberg@gmail.com972-4-6304320

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026