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

H

Hillel Yaffe Medical Center

Status

Unknown

Conditions

Iron Deficiency Anemia
Child Development
Helicobacter Pylori Infection

Study type

Observational

Funder types

Other

Identifiers

NCT02654197
HYMC-0093-15

Details and patient eligibility

About

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.

Enrollment

600 estimated patients

Sex

All

Ages

6 to 12 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

600 participants in 2 patient groups

H.pylori positive children
Description:
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
Description:
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.

Trial contacts and locations

1

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Central trial contact

Amit Hochberg, MD

Data sourced from clinicaltrials.gov

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