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

NCT ID: NCT00475527

Last Updated: 2015-08-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL

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.

Conditions

Anemia, Iron-Deficiency; Helicobacter Pylori

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

iron only

Only iron therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

iron + HP therapy

Iron + 'omeprazole,clarithromycin,amoxicillin (or metronidazole)

Group Type: EXPERIMENTAL

omeprazole,clarithromycin,amoxicillin (or metronidazole)

Intervention Type: DRUG

Interventions

omeprazole,clarithromycin,amoxicillin (or metronidazole)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Principal Investigators

Shoshana Revel-Vilk, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Hadassah Medical Organization

Jerusalem, , Israel

Countries

Israel

Other Identifiers

HP-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id