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The Effect of H. Pylori Infection on Iron Metabolism

Primary Purpose

Iron Deficiency Anemia, Helicobacter Pylori Infection

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
H. pylori treatment
Sponsored by
Seattle Institute for Biomedical and Clinical Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia focused on measuring anemia, iron-deficiency, Helicobacter pylori

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VA Puget Sound Health Care System

Outcomes

Primary Outcome Measures

Difference in iron absorption (Cmax) for H. pylori infected and uninfected IDA patients.
Change following H. pylori treatment in the iron absorption (Cmax) for H. pylori infected IDA patients.
Difference in the presence of genes related to iron metabolism for H. pylori-infected IDA patients vs. non-anemic controls.
Difference in gastritis pattern between H. pylori-infected IDA patients and non-anemic controls.

Secondary Outcome Measures

Difference in gastritis severity between H. pylori-infected IDA patients and non-anemic controls.
Difference in gastric iron concentration.
Change in Hct and ferritin values following treatment.

Full Information

First Posted
September 13, 2005
Last Updated
July 29, 2008
Sponsor
Seattle Institute for Biomedical and Clinical Research
Collaborators
PriCara, Unit of Ortho-McNeil, Inc., Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00202488
Brief Title
The Effect of H. Pylori Infection on Iron Metabolism
Official Title
The Effect of H. Pylori Infection on Iron Metabolism
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Seattle Institute for Biomedical and Clinical Research
Collaborators
PriCara, Unit of Ortho-McNeil, Inc., Eisai Inc.

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia, Helicobacter Pylori Infection
Keywords
anemia, iron-deficiency, Helicobacter pylori

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
H. pylori treatment
Primary Outcome Measure Information:
Title
Difference in iron absorption (Cmax) for H. pylori infected and uninfected IDA patients.
Title
Change following H. pylori treatment in the iron absorption (Cmax) for H. pylori infected IDA patients.
Title
Difference in the presence of genes related to iron metabolism for H. pylori-infected IDA patients vs. non-anemic controls.
Title
Difference in gastritis pattern between H. pylori-infected IDA patients and non-anemic controls.
Secondary Outcome Measure Information:
Title
Difference in gastritis severity between H. pylori-infected IDA patients and non-anemic controls.
Title
Difference in gastric iron concentration.
Title
Change in Hct and ferritin values following treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kearney, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Effect of H. Pylori Infection on Iron Metabolism

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