Helicobacter Pylori and Iron Deficiency: Prevalence of Association and Effect of Therapy

Helicobacter Pylori Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00475527
• Other study ID #: HP-HMO-CTIL
• Status: Withdrawn
• Phase: Phase 4
• First received: May 15, 2007
• Last updated: August 19, 2015

Study information

• Verified date: January 2009
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 18 Years

Eligibility

Inclusion Criteria:

• All of the children diagnosed with IDA at six large ambulatory pediatrics clinics from the Jerusalem district.

• The diagnosis of IDA would be defined as a low hemoglobin level in the presence of iron deficiency (low iron levels, high transferrin saturation and/or low ferritin).

Exclusion Criteria:

• Children with clinical symptoms fo Helicobacter Pylori, i.e. abdominal pain, peptic ulcer etc.

• Children with underlying chronic disease needing medical treatment.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Helicobacter Pylori

Intervention

Drug:
• omeprazole,clarithromycin,amoxicillin (or metronidazole)

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the raise in hemoglobin level between baseline and eight weeks later in Fe-supplemented and HP-positive children treated for HP infection and Fe-supplemented HP-positive children not treated for HP.		two years
Secondary	1. To determine the prevalence of HP infection in children with IDA in Israel, 2. To compare the demographic, clinical and laboratory findings between children diagnosed with IDA with/without HP infection.		2 years