The Effect of H. Pylori Infection on Iron Metabolism

Helicobacter Pylori Infection Clinical Trial

Official title:

The Effect of H. Pylori Infection on Iron Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00202488
• Other study ID #: 02-1807-B 03
• Secondary ID: RAB-EMR-420
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 13, 2005
• Last updated: July 29, 2008
• Start date: November 2002
• Est. completion date: September 2007

Study information

• Verified date: July 2008
• Source: Seattle Institute for Biomedical and Clinical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection
• Iron Deficiency Anemia

Intervention

Drug:
• H. pylori treatment

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Seattle Institute for Biomedical and Clinical Research	Eisai Inc., PriCara, Unit of Ortho-McNeil, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in iron absorption (Cmax) for H. pylori infected and uninfected IDA patients.
Primary	Change following H. pylori treatment in the iron absorption (Cmax) for H. pylori infected IDA patients.
Primary	Difference in the presence of genes related to iron metabolism for H. pylori-infected IDA patients vs. non-anemic controls.
Primary	Difference in gastritis pattern between H. pylori-infected IDA patients and non-anemic controls.
Secondary	Difference in gastritis severity between H. pylori-infected IDA patients and non-anemic controls.
Secondary	Difference in gastric iron concentration.
Secondary	Change in Hct and ferritin values following treatment.