Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00202488
Status:
COMPLETED
Last Update Posted:
2008-07-30
First Post:
2005-09-13
Brief Title:
The Effect of H Pylori Infection on Iron Metabolism
Sponsor:
Seattle Institute for Biomedical and Clinical Research
Organization:
Seattle Institute for Biomedical and Clinical Research
Study Overview
Official Title:
The Effect of H Pylori Infection on Iron Metabolism
Status:
COMPLETED
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RAB-EMR-420 | None | None | None |