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

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.

Study Overview

• Status: Withdrawn
• Conditions: Anemia, Iron-Deficiency; Helicobacter Pylori
• Intervention / Treatment: Drug: omeprazole,clarithromycin,amoxicillin (or metronidazole)

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 Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Hadassah Medical Organization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: iron only; Only iron therapy
Experimental: iron + HP therapy; Iron + 'omeprazole,clarithromycin,amoxicillin (or metronidazole)	Drug: omeprazole,clarithromycin,amoxicillin (or metronidazole)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Investigators: Principal Investigator: Shoshana Revel-Vilk, MD, Hadassah Medical Organization

Study record dates

Study Registration Dates

• First Submitted: May 15, 2007
• First Submitted That Met QC Criteria: May 17, 2007
• First Posted (Estimate): May 21, 2007

Study Record Updates

• Last Update Posted (Estimate): August 20, 2015
• Last Update Submitted That Met QC Criteria: August 19, 2015
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Metronidazole; Amoxicillin; Clarithromycin; Omeprazole
• Other Study ID Numbers: HP-HMO-CTIL