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

NCT ID: NCT02654197

Last Updated: 2016-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-05-31

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.

Detailed Description

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Conditions

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Helicobacter Pylori Infection Iron Deficiency Anemia Child Development

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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H.pylori positive children

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.

No interventions assigned to this group

H.Pylori negative children

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.

No interventions assigned to this group

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hillel Yaffe Medical Center

Hadera, , Israel

Site Status

Countries

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Israel

Central Contacts

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Amit Hochberg, MD

Role: CONTACT

972-4-6304320

Facility Contacts

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Amit Hochberg, MD

Role: primary

972-4-630-4320

Other Identifiers

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HYMC-0093-15

Identifier Type: -

Identifier Source: org_study_id

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