Helicobacter Pylori and Iron Deficiency: Prevalence of Association and Effect of Therapy
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anemia, Iron-Deficiency Helicobacter Pylori |
Drug: omeprazole,clarithromycin,amoxicillin (or metronidazole) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
- 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. [ Time Frame: two years ]
- 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. [ Time Frame: 2 years ]
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.
Eligibility| Ages Eligible for Study: | 6 Months to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00475527 History of Changes |
| Other Study ID Numbers: | HP-HMO-CTIL |
| Study First Received: | May 15, 2007 |
| Last Updated: | January 28, 2009 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Additional relevant MeSH terms:
|
Anemia Anemia, Iron-Deficiency Hematologic Diseases Anemia, Hypochromic Iron Metabolism Disorders Metabolic Diseases Amoxicillin Clarithromycin Metronidazole Omeprazole Anti-Bacterial Agents Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antiprotozoal Agents Antiparasitic Agents Anti-Ulcer Agents Gastrointestinal Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protein Synthesis Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013