Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00475527
Status:
WITHDRAWN
Last Update Posted:
2015-08-20
First Post:
2007-05-15
Brief Title:
Helicobacter Pylori and Iron Deficiency Prevalence of Association and Effect of Therapy
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
None
Status:
WITHDRAWN
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
problem of accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Iron deficiency anemia IDA is a major health problem in children effecting up to 20 of young children Helicobacter pylori HP infection is also reported to be prevalent in children Several large epidemiologic studies support an association between HP infection and lower iron stores Other small studies suggest improvement in anemia following HP treatment
We assume that the prevalence of HP infection in Israeli children diagnosed with IDA is high and that that adding therapy for HP in those children will improve the response to iron deficiency
We assume that the prevalence of HP infection in Israeli children diagnosed with IDA is high and that that adding therapy for HP in those children will improve the response to iron deficiency
Detailed Description:
This is a prospective randomized control study which will be conducted at six large ambulatory pediatrics clinics from the Jerusalem district All of the children diagnosed with IDA would be eligible to join the study after informed consent will be obtained Ethics committee approval is obtained Analysis of stool samples will be carried out by the HP Stool antigen EIA HpSA Premier Platinum HpSA Meridian Diagnostics inc Cincinnati OH USA All children enrolled will be treated with standard Fe therapy Children with positive HpSA will be randomized controlled for age and clinic to receive or not receive antibiotics treatment Assessment of response to iron therapy will be done at eight weeks later The prevalence of HP infection in children with diagnosed with IDA would be reported Statistical analysis will compare the baseline data between HP-positive and -negative children and the response to Fe between the three study groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None