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

January 11, 2016 updated by: Hillel Yaffe Medical Center
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Hadera, Israel, 38100
        • Hillel Yaffe Medical Center
        • Contact:
        • Sub-Investigator:
          • Khitam Muhsen, PhD
        • Sub-Investigator:
          • Daniel Cohen, PhD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy children aged 6-12 years residing in the catchment areas of primary care clinics in the Hadera sub-district of Israel.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Intelligence quotient (IQ) scores
Time Frame: Two years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

December 14, 2015

First Submitted That Met QC Criteria

January 11, 2016

First Posted (Estimate)

January 13, 2016

Study Record Updates

Last Update Posted (Estimate)

January 13, 2016

Last Update Submitted That Met QC Criteria

January 11, 2016

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYMC-0093-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Iron Deficiency Anemia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe