The Effect of H. Pylori Infection on Iron Metabolism
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Difference in iron absorption (Cmax) for H. pylori infected and uninfected IDA patients.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
次要结局
- 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.