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The Effect of H. Pylori Infection on Iron Metabolism

This study has been completed.
Sponsor:
Collaborators:
PriCara, Unit of Ortho-McNeil, Inc.
Eisai Inc.
Information provided by:
Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier:
NCT00202488
First received: September 13, 2005
Last updated: July 29, 2008
Last verified: July 2008
  Purpose

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.


Condition Intervention Phase
Iron Deficiency Anemia
Helicobacter Pylori Infection
Drug: H. pylori treatment
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of H. Pylori Infection on Iron Metabolism

Resource links provided by NLM:


Further study details as provided by Seattle Institute for Biomedical and Clinical Research:

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.

Estimated Enrollment: 39
Study Start Date: November 2002
Estimated Study Completion Date: September 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202488

Locations
United States, Washington
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Seattle Institute for Biomedical and Clinical Research
PriCara, Unit of Ortho-McNeil, Inc.
Eisai Inc.
Investigators
Principal Investigator: David Kearney, MD University of Washington
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00202488     History of Changes
Other Study ID Numbers: 02-1807-B 03, RAB-EMR-420
Study First Received: September 13, 2005
Last Updated: July 29, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Seattle Institute for Biomedical and Clinical Research:
anemia, iron-deficiency
Helicobacter pylori

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Communicable Diseases
Helicobacter Infections
Infection
Anemia
Anemia, Hypochromic
Bacterial Infections
Gram-Negative Bacterial Infections
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014