The Effect of H. Pylori Infection on Iron Metabolism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2007-09-30

Brief Summary

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The purpose of this study is to determine if Helicobacter pylori (H. pylori) gastritis results in abnormal iron metabolism in patients with iron deficiency anemia (IDA), and to determine if this is due to strain variations in the H. pylori organism.

Detailed Description

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There is suggestive evidence that H. pylori gastritis (without peptic ulcer disease) is a cause of IDA. There have been individual case reports and case series describing patients with refractory IDA that resolved following successful H. pylori treatment. The effect of H. pylori on iron metabolism will be studied through specific aims: 1. To assess whether H. pylori results in abnormal oral iron absorption 2. To assess if differences in H. pylori strains are associated with iron deficiency due to: a. genetic differences in H. pylori strains or b. differences in the pattern of gastritis which could be due to host, bacterial or environmental factors 3. To assess if H. pylori infection results in storage of iron in the gastric mucosa and an elevated gastric iron concentration. The study will consist of three aspects: 1. Determining whether oral iron absorption is abnormal for H. pylori-positive IDA patients, and comparison of oral iron absorption for H. pylori positive and negative IDA patients. This will also include an experimental component in which oral iron absorption will be repeated after H. pylori treatment for H. pylori-infected IDA subjects (and after an equivalent time period for H. pylori negative controls to exclude changes in iron absorption that occur over time). 2. Comparison of H. pylori strain characteristics for IDA patients and non-anemic H. pylori-infected controls. Characterization of H. pylori strains will include: genetic analysis using a whole genome microarray technique that assesses the presence or absence of H. pylori genes, evaluation of expression of genes related to iron metabolism, and comparison of pattern of gastritis (pan gastritis vs. antrum-predominant). 3. Determination of whether H. pylori stores a significant quantity of iron in the gastric mucosa in vivo. This will be assessed by measuring the iron concentration in mucosal biopsy specimens and comparing results for H. pylori-infected IDA patients to H. pylori-uninfected IDA controls.

Conditions

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Iron Deficiency Anemia Helicobacter Pylori Infection

Keywords

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anemia, iron-deficiency Helicobacter pylori

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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H. pylori treatment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age \> 18 years
* iron deficiency anemia (IDA) defined as: Hgb \< 14 g/L for men and 12 g/L for women, and a serum ferritin level less than 45 ug/L

Exclusion Criteria

* Obvious non-GI cause of blood loss
* Chronic renal failure (BUN\>60, Creatinine \> 4)
* Hemolytic anemia, thalassemia, aplastic anemia
* Known alcoholism or cirrhosis of the liver
* Regular use (\>3x weekly) of NSAIDS
* Prior gastric resection
* Celiac disease
* Known GI or hematologic malignancy
* Known inflammatory bowel disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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David Kearney, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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VA Puget Sound Health Care System

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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RAB-EMR-420

Identifier Type: -

Identifier Source: secondary_id

02-1807-B 03