Helicobacter Pylori and Iron Deficiency: Prevalence of Association and Effect of Therapy - Full Text View

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00475527

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 IV

MedlinePlus related topics: Anemia

Drug Information available for: Amoxicillin Amoxicillin sodium Amoxicillin trihydrate Clarithromycin Metronidazole Metronidazole hydrochloride Metronidazole phosphate Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Study Start Date:	January 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	6 Months to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475527

Contacts

Contact: Shoshana Revel-Vilk, MD	0097226777408	shoshanav@hadassah.org.il
Contact: Eyal Shtaier, MD	00972226777408	eyals@hadassah.org.il

Locations

Israel
Hadassah Medical Organization	Recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD 0097226776095 arik@hadassah.org.il
Contact: Hadas Lemberg, PhD 0097226777572 lhadas@hadassah.org.il
Principal Investigator: Shoshana Revel-Vilk, MD

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:

Shoshana Revel-Vilk, MD

Hadassah Medical Center

More Information

Study ID Numbers:	HP-HMO-CTIL
Study First Received:	May 15, 2007
Last Updated:	January 10, 2008
ClinicalTrials.gov Identifier:	NCT00475527
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Study placed in the following topic categories:

Metronidazole
Clarithromycin
Amoxicillin
Metabolic Diseases
Hematologic Diseases
Anemia

Omeprazole
Iron Metabolism Disorders
Metabolic disorder
Iron
Anemia, Iron-Deficiency

Additional relevant MeSH terms:

Protein Synthesis Inhibitors
Anti-Infective Agents
Anti-Bacterial Agents
Antiparasitic Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action

Radiation-Sensitizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Anemia, Hypochromic
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009