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

Phase 4

Withdrawn

• Conditions: Anemia, Iron-Deficiency; Helicobacter Pylori
• Interventions: Drug: omeprazole,clarithromycin,amoxicillin (or metronidazole)

• Registration Number: NCT00475527
• Lead Sponsor: Hadassah Medical Organization

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.

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 Timeline

• Study First Submitted: 2007-05-15
• Study First Submitted QC: 2007-05-17
• Study First Posted: 2007-05-21
• Status Verified: 2009-01
• Last Update Submitted: 2015-08-19
• Last Update Posted: 2015-08-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iron + HP therapy	omeprazole,clarithromycin,amoxicillin (or metronidazole)	Iron + 'omeprazole,clarithromycin,amoxicillin (or metronidazole)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel